<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01669382</url>
  </required_header>
  <id_info>
    <org_study_id>Med2UKEr1/2012</org_study_id>
    <nct_id>NCT01669382</nct_id>
  </id_info>
  <brief_title>Angio-Seal® vs. Exo-Seal® for Closure of Arterial Puncture Sites</brief_title>
  <official_title>ACCESS: A Randomized, Multicenter, Single-Blinded Trial to Compare the Extrafemoral Closure Device Exo-Seal® and the Collagen-based Intravascular Device Angio-SealTM for Arterial Puncture Site Closure.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital Erlangen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital Erlangen</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background:&#xD;
&#xD;
      Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve&#xD;
      patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions&#xD;
      (PCI). Despite higher complications rates in earlier studies, current data suggest similar&#xD;
      complication rates or better outcomes after the use of VCD as compared to manual compression.&#xD;
      ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which&#xD;
      occludes the puncture channel. Whether the use of this extravascular closure device is as&#xD;
      effective as the more widely used plug/anchor mediated devices, has not been evaluated so&#xD;
      far.&#xD;
&#xD;
      We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the&#xD;
      extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated&#xD;
      AngioSeal system.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      304 patients receiving diagnostic angiography and/or PCI will be included in three centers.&#xD;
      Exclusion criteria are contraindications for any VCD including 1. severe calcification of the&#xD;
      access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound&#xD;
      femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac&#xD;
      artery, 5. marked obesity or cachexia (BMI &gt;40 or &lt;20) and 6. patients on continuous&#xD;
      medication with oral anticoagulants.&#xD;
&#xD;
      After the procedure, angiography of the accessed femoral artery is performed to rule out&#xD;
      major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common&#xD;
      or the superficial femoral artery, or a location of the puncture site in the bifurcation of&#xD;
      the profundal femoral artery.&#xD;
&#xD;
      We hypothesise, that the use of an extravascular closure device is not inferior to an&#xD;
      anchor/plug mediated device regarding the occurrence of the following complications:&#xD;
      bleeding, need for vascular surgery and device failure (primary endpoints). Secondary&#xD;
      endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm&#xD;
      within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be&#xD;
      defined according to the TIMI criteria. The study is actively enrolling patients, last&#xD;
      inclusion will take place in September 2012.&#xD;
&#xD;
      Results and Conclusions:&#xD;
&#xD;
      Outcome data including the primary endpoint (bleeding, need for vascular surgery and device&#xD;
      failure) will be presented for the first time.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Introduction In patients undergoing percutaneous coronary interventions (PCI) there is a rate&#xD;
      of vascular complications of 0.8% to 5.5% (1). Albeit femoral sheaths sizes were reduced,&#xD;
      arterial compression and long-term dressing after PCI still bear tremendous discomfort and&#xD;
      groin pain for the patients. Furthermore, manual compression of the puncture site should be&#xD;
      performed until activated clotting time is below 180 seconds (2).&#xD;
&#xD;
      Therefore, vascular closure devices (VCD) were developed to reduce access site bleedings, to&#xD;
      improve patients´ comfort, and to accelerate ambulation after PCI.&#xD;
&#xD;
      The hemostatic puncture closure device Angio-Seal (St. Jude Medical, St. Paul, MS, USA) is a&#xD;
      collagen based plug system with an anchor in the inner vessel wall. ExoSeal (Cordis, Warren,&#xD;
      NJ, USA) is a extravascular polyglycol acid (PGA) plug, which closes the puncture site on an&#xD;
      extravascular basis while occluding the puncture channel.&#xD;
&#xD;
      The aim of the current, randomized study is, to evaluate the effectiveness, safety and&#xD;
      reliability of 2 different vascular closure devices.&#xD;
&#xD;
      Methods Consecutive patients with stable angina pectoris or silent ischemia with a positive&#xD;
      stress test will be randomized to either Angio-Seal or Exo-Seal, and included into the study&#xD;
      after giving written informed consent.&#xD;
&#xD;
      Patients with contraindications for any VCD including 1. severe calcifications of the vessel&#xD;
      site, 2. severe peripheral artery disease, 3. puncture in the origin of the femoral profundal&#xD;
      artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac artery,&#xD;
      and 5. marked obesity (BMI &gt;40) or 6. cachexia (BMI &lt;20) will be excluded from the study (3).&#xD;
      As clinical exclusion criteria will serve: 1. any emergency intervention, 2. the use of&#xD;
      Glycoprotein IIb/IIIa-antagonists during the intervention, and 3. patients on continuous&#xD;
      medication with oral anticoagulants.&#xD;
&#xD;
      All patients will be loaded with either 300 mg or 600 mg of Clopidogrel or 60 mg of Prasugrel&#xD;
      or 180 mg of Ticagrelor, followed by a maintenance dose of 75 mg or 150 mg of Clopidogrel or&#xD;
      5 mg or 10 mg of Prasugrel, or 90 mg of Ticagrelor prior to the intervention. After insertion&#xD;
      of a 6 F sheath, unfractionated Heparin (UF) will be given until an activated clotting&#xD;
      time-level (ACT) of 250 s will be achieved. The use of low -molecular weight Heparin (LMWH)&#xD;
      according to the recommendations of the manufacturers for the purpose of anticoagulation&#xD;
      during PCI is possible. The simultaneous use of UF and LMWH should be avoided.&#xD;
&#xD;
      Patients should receive PCI according to standard protocols (8). After the procedure, an&#xD;
      angiography of the accessed femoral artery should be performed to rule out major risk factors&#xD;
      for retroperitoneal hemorrhage, relevant peripheral stenoses of the common or the superficial&#xD;
      femoral artery, or a location of the puncture site in the bifurcation of the profundal&#xD;
      femoral artery (9). In addition, this method will identify patients with a non-femoral artery&#xD;
      sheath insertion, for which the VCD utilization is not proven (10). Patients with strong&#xD;
      tortuosity and/or calcification of the femoral arteries should also be excluded from the&#xD;
      study (see exclusion criteria).&#xD;
&#xD;
      Towards the end of the intervention the ACT should be recorded again: Angio-Seal or ExoSeal&#xD;
      may be implanted when ACT is &lt; 300s. In patients randomized to manual compression with or&#xD;
      without patch the sheath should be removed when the ACT is &lt; 180s.&#xD;
&#xD;
      The use of protamine is left to the discretion of the operator. In patients randomized to&#xD;
      either Angio-Seal or Exo-Seal the placement should be performed using the manufacturer´s&#xD;
      recommended technique. The operator should be familiar with any device used in the study, and&#xD;
      should have performed vascular closure with those devices at least fifty times.&#xD;
&#xD;
      After insertion of the VCD a circular groin dressing will be applied, and patients will be&#xD;
      immobilized for 4 hours. After this, the arterial puncture site will be examined, and&#xD;
      auscultation will be performed. If there is no relevant complication, ambulation will be&#xD;
      initiated.&#xD;
&#xD;
      Pain during closure procedure or manual compression will be categorized according to the Borg&#xD;
      scale, with minor pain defined as Borg &lt; 5 and major pain as Borg ≥ 5 (13).&#xD;
&#xD;
      In patients with manual compression with or without patch, immobilization will last 8 hours.&#xD;
      After this, inspection of the puncture site will be performed as mentioned above.&#xD;
&#xD;
      Anticoagulation either with unfractionated heparin or low molecular weight heparin will be&#xD;
      restarted 6 hours after resolution of the dressing. On the subsequent day, ultrasound and&#xD;
      Doppler spectral analysis of the puncture site will be performed in all patients.&#xD;
&#xD;
      Complications will be assessed as being major or minor: Major complications are defined as&#xD;
      need for vascular surgery, false aneurysm, AV-fistula, strong pain (Borg ≥ 5), hematoma ≥ 5&#xD;
      cm and major bleeding, whereas minor pain, hematoma &lt; 5 cm and new wound dressing will be&#xD;
      classified as minor complications. Bleeding will be identified as bleeding according to the&#xD;
      TIMI criteria (12). TIMI major bleeding is defined as hemoglobin drop &gt; 5 g/dl (with or&#xD;
      without an identified site), TIMI &quot;loss no site&quot; as a haemoglobin drop &gt; 4 g/dl but &lt; 5 g/dl&#xD;
      without an identified bleeding site, and TIMI minor bleeding as a hemoglobin drop &gt; 3 g/dl&#xD;
      but &lt; 5 g/dl with bleeding from a known site or spontaneous gross hematuria.&#xD;
&#xD;
      Again pain will be categorized according to the Borg scale, with minor pain defined as Borg &lt;&#xD;
      5 and major pain as Borg ≥ 5 (13).&#xD;
&#xD;
      Demographic and procedural data will be prospectively collected using a standardized&#xD;
      procedural data sheet. This includes date and type of intervention, sheath size,&#xD;
      procedure-related drug doses, and number of previous interventions. Major or minor&#xD;
      complications, as well as the time of events will be recorded.&#xD;
&#xD;
      Statistical analysis Randomization will be performed Statistical analyses will be performed&#xD;
      with SPSS version 16.0 (SPSS Inc., Chicago, IL, USA). Continuous data are expressed as mean&#xD;
      values +/- standard deviation. For comparisons between paired data the students t-test will&#xD;
      be used. A p-value &lt; 0.05 will be regarded as statistically significant.&#xD;
&#xD;
      Risk-benefit ratio Achieving adequate hemostasis is crucial for the prevention of access site&#xD;
      complications in patients undergoing PCI (3). The occurrence of vascular complications was an&#xD;
      independent predictor of nonfatal myocardial infarction or death within one year after&#xD;
      intervention (14), and has been associated with a significant increase in mortality (15).&#xD;
      Advanced age, female gender, pre-existing vascular disease, emergent procedures, low body&#xD;
      surface area (4, 8, 14), diabetes, hypertension, and cigarette smoking (15, 16) are also&#xD;
      associated with an increased bleeding risk. Therefore adequate hemostasis still remains a&#xD;
      challenge in interventional cardiology.&#xD;
&#xD;
      The recently introduced extravascular closure device ExoSeal theoretically offer some&#xD;
      advantages. First, there is no foreign body, which is introduced into the artery, which, once&#xD;
      misplaced potentially can lead to an occlusion of the artery, or to inflammation or allergic&#xD;
      reactions. In addition to that , those devices might be used in patients with common&#xD;
      contraindications for VCD´s like calcification, peripheral artery disease and tortuosity of&#xD;
      the artery.&#xD;
&#xD;
      Since these devices are already introduced, but not evaluated sufficiently, there is need for&#xD;
      a randomized comparison with an established system.&#xD;
&#xD;
      The risk-benefit ratio is well on the site of benefit, since all devices are regularly used&#xD;
      in interventional cardiology and the estimated complication rate is in the range or even&#xD;
      lower, than those, reported in the literature.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2012</start_date>
  <completion_date type="Actual">September 2012</completion_date>
  <primary_completion_date type="Actual">September 2012</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>bleeding, need for vascular surgery and device failure</measure>
    <time_frame>24 hours</time_frame>
    <description>bleeding, need for vascular surgery and device failure will be measured as primary endpoints within the first 24 hours.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.</measure>
    <time_frame>24 hours</time_frame>
    <description>Secondary endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>lab values</measure>
    <time_frame>24 hours</time_frame>
    <description>red blood count after 24 hours</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">304</enrollment>
  <condition>Acute Coronary Syndromes</condition>
  <condition>Stable Angina Pectoris</condition>
  <arm_group>
    <arm_group_label>Exo Seal system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Percutaneous coronary intervention</description>
  </arm_group>
  <arm_group>
    <arm_group_label>AngioSeal system</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>percutaneous coronary intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>percutaneous coronary intervention</intervention_name>
    <description>after the intervention patients are randomized to either Angio Seal or Exo Seal</description>
    <arm_group_label>AngioSeal system</arm_group_label>
    <arm_group_label>Exo Seal system</arm_group_label>
    <other_name>Exo Seal for closure of arterial puncture site</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patients who receive coronary angiography/intervention with an 6 F sheath&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  severe calcification of the access vessel,&#xD;
&#xD;
          -  severe peripheral artery disease,&#xD;
&#xD;
          -  puncture in the origin of the profound femoral artery,&#xD;
&#xD;
          -  non-femoral sheath insertion,&#xD;
&#xD;
          -  marked tortuosity of the femoral or iliac artery,&#xD;
&#xD;
          -  marked obesity or cachexia (BMI &gt;40 or &lt;20)&#xD;
&#xD;
          -  patients on continuous medication with oral anticoagulants.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Harald Rittger, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universitätsklinikum Erlangen, Medizinische Klinik 2, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Coburg</name>
      <address>
        <city>Coburg</city>
        <zip>96450</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Erlangen; Medizinische Klinik 2</name>
      <address>
        <city>Erlangen</city>
        <zip>91054</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Gießen, Klinik für Kardiologie</name>
      <address>
        <city>Gießen</city>
        <zip>35392</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>February 2015</verification_date>
  <study_first_submitted>August 9, 2012</study_first_submitted>
  <study_first_submitted_qc>August 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2012</study_first_posted>
  <last_update_submitted>February 2, 2015</last_update_submitted>
  <last_update_submitted_qc>February 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 4, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital Erlangen</investigator_affiliation>
    <investigator_full_name>Harald Rittger</investigator_full_name>
    <investigator_title>Priv.-Doz. Dr. Harald Rittger</investigator_title>
  </responsible_party>
  <keyword>AngioSeal, ExoSeal, PCI, puncture site</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acute Coronary Syndrome</mesh_term>
    <mesh_term>Angina Pectoris</mesh_term>
    <mesh_term>Angina, Stable</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01669382
org study id: Med2UKEr1/2012
nct id: NCT01669382
lead sponsor: 
has dmc: Yes
Background:

      Vascular closure devices (VCD) were developed to reduce access site bleedings, to improve
      patients´ comfort, and to accelerate ambulation after percutaneous coronary interventions
      (PCI). Despite higher complications rates in earlier studies, current data suggest similar
      complication rates or better outcomes after the use of VCD as compared to manual compression.
      ExoSeal (Cordis, Warren, NJ, USA) is a new, extravascular polyglycol acid (PGA) plug which
      occludes the puncture channel. Whether the use of this extravascular closure device is as
      effective as the more widely used plug/anchor mediated devices, has not been evaluated so
      far.

      We performed a randomized, multicentre, single-blinded trial to compare the efficacy of the
      extravascular closure device ExoSeal in comparison to the collagen-based plug/anchor mediated
      AngioSeal system.

      Methods:

      304 patients receiving diagnostic angiography and/or PCI will be included in three centers.
      Exclusion criteria are contraindications for any VCD including 1. severe calcification of the
      access vessel, 2. severe peripheral artery disease, 3. puncture in the origin of the profound
      femoral artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac
      artery, 5. marked obesity or cachexia (BMI >40 or <20) and 6. patients on continuous
      medication with oral anticoagulants.

      After the procedure, angiography of the accessed femoral artery is performed to rule out
      major risk factors for retroperitoneal hemorrhage, relevant peripheral stenoses of the common
      or the superficial femoral artery, or a location of the puncture site in the bifurcation of
      the profundal femoral artery.

      We hypothesise, that the use of an extravascular closure device is not inferior to an
      anchor/plug mediated device regarding the occurrence of the following complications:
      bleeding, need for vascular surgery and device failure (primary endpoints). Secondary
      endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm
      within 24 hours after insertion of the device. Power was 80%, alpha 0.05. Bleeding will be
      defined according to the TIMI criteria. The study is actively enrolling patients, last
      inclusion will take place in September 2012.

      Results and Conclusions:

      Outcome data including the primary endpoint (bleeding, need for vascular surgery and device
      failure) will be presented for the first time.
Introduction In patients undergoing percutaneous coronary interventions (PCI) there is a rate
      of vascular complications of 0.8% to 5.5% (1). Albeit femoral sheaths sizes were reduced,
      arterial compression and long-term dressing after PCI still bear tremendous discomfort and
      groin pain for the patients. Furthermore, manual compression of the puncture site should be
      performed until activated clotting time is below 180 seconds (2).

      Therefore, vascular closure devices (VCD) were developed to reduce access site bleedings, to
      improve patients´ comfort, and to accelerate ambulation after PCI.

      The hemostatic puncture closure device Angio-Seal (St. Jude Medical, St. Paul, MS, USA) is a
      collagen based plug system with an anchor in the inner vessel wall. ExoSeal (Cordis, Warren,
      NJ, USA) is a extravascular polyglycol acid (PGA) plug, which closes the puncture site on an
      extravascular basis while occluding the puncture channel.

      The aim of the current, randomized study is, to evaluate the effectiveness, safety and
      reliability of 2 different vascular closure devices.

      Methods Consecutive patients with stable angina pectoris or silent ischemia with a positive
      stress test will be randomized to either Angio-Seal or Exo-Seal, and included into the study
      after giving written informed consent.

      Patients with contraindications for any VCD including 1. severe calcifications of the vessel
      site, 2. severe peripheral artery disease, 3. puncture in the origin of the femoral profundal
      artery, 3. non-femoral sheath insertion, 4. marked tortuosity of the femoral or iliac artery,
      and 5. marked obesity (BMI >40) or 6. cachexia (BMI <20) will be excluded from the study (3).
      As clinical exclusion criteria will serve: 1. any emergency intervention, 2. the use of
      Glycoprotein IIb/IIIa-antagonists during the intervention, and 3. patients on continuous
      medication with oral anticoagulants.

      All patients will be loaded with either 300 mg or 600 mg of Clopidogrel or 60 mg of Prasugrel
      or 180 mg of Ticagrelor, followed by a maintenance dose of 75 mg or 150 mg of Clopidogrel or
      5 mg or 10 mg of Prasugrel, or 90 mg of Ticagrelor prior to the intervention. After insertion
      of a 6 F sheath, unfractionated Heparin (UF) will be given until an activated clotting
      time-level (ACT) of 250 s will be achieved. The use of low -molecular weight Heparin (LMWH)
      according to the recommendations of the manufacturers for the purpose of anticoagulation
      during PCI is possible. The simultaneous use of UF and LMWH should be avoided.

      Patients should receive PCI according to standard protocols (8). After the procedure, an
      angiography of the accessed femoral artery should be performed to rule out major risk factors
      for retroperitoneal hemorrhage, relevant peripheral stenoses of the common or the superficial
      femoral artery, or a location of the puncture site in the bifurcation of the profundal
      femoral artery (9). In addition, this method will identify patients with a non-femoral artery
      sheath insertion, for which the VCD utilization is not proven (10). Patients with strong
      tortuosity and/or calcification of the femoral arteries should also be excluded from the
      study (see exclusion criteria).

      Towards the end of the intervention the ACT should be recorded again: Angio-Seal or ExoSeal
      may be implanted when ACT is < 300s. In patients randomized to manual compression with or
      without patch the sheath should be removed when the ACT is < 180s.

      The use of protamine is left to the discretion of the operator. In patients randomized to
      either Angio-Seal or Exo-Seal the placement should be performed using the manufacturer´s
      recommended technique. The operator should be familiar with any device used in the study, and
      should have performed vascular closure with those devices at least fifty times.

      After insertion of the VCD a circular groin dressing will be applied, and patients will be
      immobilized for 4 hours. After this, the arterial puncture site will be examined, and
      auscultation will be performed. If there is no relevant complication, ambulation will be
      initiated.

      Pain during closure procedure or manual compression will be categorized according to the Borg
      scale, with minor pain defined as Borg < 5 and major pain as Borg ≥ 5 (13).

      In patients with manual compression with or without patch, immobilization will last 8 hours.
      After this, inspection of the puncture site will be performed as mentioned above.

      Anticoagulation either with unfractionated heparin or low molecular weight heparin will be
      restarted 6 hours after resolution of the dressing. On the subsequent day, ultrasound and
      Doppler spectral analysis of the puncture site will be performed in all patients.

      Complications will be assessed as being major or minor: Major complications are defined as
      need for vascular surgery, false aneurysm, AV-fistula, strong pain (Borg ≥ 5), hematoma ≥ 5
      cm and major bleeding, whereas minor pain, hematoma < 5 cm and new wound dressing will be
      classified as minor complications. Bleeding will be identified as bleeding according to the
      TIMI criteria (12). TIMI major bleeding is defined as hemoglobin drop > 5 g/dl (with or
      without an identified site), TIMI "loss no site" as a haemoglobin drop > 4 g/dl but < 5 g/dl
      without an identified bleeding site, and TIMI minor bleeding as a hemoglobin drop > 3 g/dl
      but < 5 g/dl with bleeding from a known site or spontaneous gross hematuria.

      Again pain will be categorized according to the Borg scale, with minor pain defined as Borg <
      5 and major pain as Borg ≥ 5 (13).

      Demographic and procedural data will be prospectively collected using a standardized
      procedural data sheet. This includes date and type of intervention, sheath size,
      procedure-related drug doses, and number of previous interventions. Major or minor
      complications, as well as the time of events will be recorded.

      Statistical analysis Randomization will be performed Statistical analyses will be performed
      with SPSS version 16.0 (SPSS Inc., Chicago, IL, USA). Continuous data are expressed as mean
      values +/- standard deviation. For comparisons between paired data the students t-test will
      be used. A p-value < 0.05 will be regarded as statistically significant.

      Risk-benefit ratio Achieving adequate hemostasis is crucial for the prevention of access site
      complications in patients undergoing PCI (3). The occurrence of vascular complications was an
      independent predictor of nonfatal myocardial infarction or death within one year after
      intervention (14), and has been associated with a significant increase in mortality (15).
      Advanced age, female gender, pre-existing vascular disease, emergent procedures, low body
      surface area (4, 8, 14), diabetes, hypertension, and cigarette smoking (15, 16) are also
      associated with an increased bleeding risk. Therefore adequate hemostasis still remains a
      challenge in interventional cardiology.

      The recently introduced extravascular closure device ExoSeal theoretically offer some
      advantages. First, there is no foreign body, which is introduced into the artery, which, once
      misplaced potentially can lead to an occlusion of the artery, or to inflammation or allergic
      reactions. In addition to that , those devices might be used in patients with common
      contraindications for VCD´s like calcification, peripheral artery disease and tortuosity of
      the artery.

      Since these devices are already introduced, but not evaluated sufficiently, there is need for
      a randomized comparison with an established system.

      The risk-benefit ratio is well on the site of benefit, since all devices are regularly used
      in interventional cardiology and the estimated complication rate is in the range or even
      lower, than those, reported in the literature.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: bleeding, need for vascular surgery and device failure
time frame: 24 hours
description: bleeding, need for vascular surgery and device failure will be measured as primary endpoints within the first 24 hours.
measure: occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.
time frame: 24 hours
description: Secondary endpoints are the occurrence of false aneurysms, severe pain (Borg ≥ 5), and hematoma ≥ 5 cm within 24 hours after insertion of the device.
measure: lab values
time frame: 24 hours
description: red blood count after 24 hours
arm group label: Exo Seal system
arm group type: Active Comparator
description: Percutaneous coronary intervention
arm group label: AngioSeal system
arm group type: Active Comparator
description: percutaneous coronary intervention
intervention type: Device
intervention name: percutaneous coronary intervention
description: after the intervention patients are randomized to either Angio Seal or Exo Seal
arm group label: AngioSeal system
arm group label: Exo Seal system
other name: Exo Seal for closure of arterial puncture site
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Harald Rittger, MD
role: Principal Investigator
affiliation: Universitätsklinikum Erlangen, Medizinische Klinik 2, Germany
facility: 
facility: 
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: University Hospital Erlangen
investigator full name: Harald Rittger
investigator title: Priv.-Doz. Dr. Harald Rittger
mesh term: Acute Coronary Syndrome
mesh term: Angina Pectoris
mesh term: Angina, Stable