<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/NCT02214030</url>
  </required_header>
  <id_info>
    <org_study_id>AFCD-03</org_study_id>
    <secondary_id>AUH-03</secondary_id>
    <nct_id>NCT02214030</nct_id>
  </id_info>
  <brief_title>Efficacy Study of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis</brief_title>
  <official_title>A Randomized Comparison of Assiut Femoral Compression Device Versus Manual Compression in the Achievement of Hemostasis After Percutaneous Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assiut University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study was performed to evaluate the safety and efficacy of a locally designed Assiut&#xD;
      Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices&#xD;
      have been developed thorough the past decades without being strongly implemented in the&#xD;
      catheterization laboratory. Their limited adoption reflects concerns of high cost and&#xD;
      conflicting data regarding their safety&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the&#xD;
      standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI&#xD;
      instead of conventional 6 hours. To standardize compression times, AFCD were applied to&#xD;
      patient and complete femoral artery compression were applied for 5 minutes, followed by a&#xD;
      gradual release of pressure till distal pulse is palpated. Each patient received a minimum of&#xD;
      13 minutes of compression, with further compression applied only if full hemostasis had not&#xD;
      been achieved at that point with maximum of 30 minutes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <start_date type="Actual">September 2013</start_date>
  <completion_date type="Actual">December 2018</completion_date>
  <primary_completion_date type="Actual">December 2018</primary_completion_date>
  <phase>N/A</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time-To-Ambulation (TTA), measured in hours</measure>
    <time_frame>TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation</time_frame>
    <description>Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression</description>
  </primary_outcome>
  <primary_outcome>
    <measure>the absence of major adverse events on discharge</measure>
    <time_frame>24 post procedure</time_frame>
    <description>major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device success:</measure>
    <time_frame>5 minutes during application</time_frame>
    <description>This was defined as easy application of the device with good fixation and stability and achieving final hemostasis. Device Stability was defined as absence of tilt and/or mobility after application of the device on top of the patient groin. Assessment of the device application was performed using a questionnaire with a scale of three grades; &quot;Easy&quot;, &quot;Difficult&quot; and &quot;Requires Improvement&quot;. Assessment of stability and fixation of the device was performed on a scale defined as &quot;Very Good&quot;, &quot;Good&quot; and &quot;Bad&quot;.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Procedure success</measure>
    <time_frame>24 h post procedure</time_frame>
    <description>This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Time-To-Hemostasis (TTH), measured in minutes.</measure>
    <time_frame>TTH was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to the time hemostasis was achieved</time_frame>
    <description>Hemostasis was defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma</description>
  </other_outcome>
  <other_outcome>
    <measure>Minor complications:</measure>
    <time_frame>24h post procedure</time_frame>
    <description>Any oozing (leakage of blood from the puncture site requiring digital pressure), ecchymosis (bleeding into subcutaneous tissue planes causing bluish-purple discoloration &gt; 4cm in diameter), hematoma (non pulsatile mass &gt; 1 cm in diameter), and infections treatable with oral antibiotics</description>
  </other_outcome>
  <other_outcome>
    <measure>Patient discomfort:</measure>
    <time_frame>within 10 minutes of device application</time_frame>
    <description>was assessed based on a short form of the McGill Pain Questionnaire using a Present Pain Intensity (PPI) scale that rated pain from 0 (no pain) to 5 (excruciating).</description>
  </other_outcome>
  <other_outcome>
    <measure>Vasovagal manifestations</measure>
    <time_frame>within 10 minutes of device application</time_frame>
    <description>(sweating, bradycardia, nausea and vomiting) were recorded.</description>
  </other_outcome>
  <other_outcome>
    <measure>Time the patient is deemed eligible for hospital discharge</measure>
    <time_frame>within 24 hours post procedure</time_frame>
    <description>Time the patient is deemed eligible for hospital discharge based on the report of the attending resident</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Common Femoral Artery Injury</condition>
  <condition>Other Vascular Adverse Event</condition>
  <arm_group>
    <arm_group_label>Assiut Femoral Compression Device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the sheaths were removed 2 hours after PCI instead of conventional 6hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure over the ensuing 8 minutes. Therefore each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual compression</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Assiut Femoral Compression Device</intervention_name>
    <description>Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.</description>
    <arm_group_label>Assiut Femoral Compression Device</arm_group_label>
    <arm_group_label>Manual compression</arm_group_label>
    <other_name>AFCD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients between 18 and 85 years of age,&#xD;
&#xD;
          -  Scheduled to undergo an elective PCI via arterial puncture of common femoral artery&#xD;
             were eligible for enrollment in the study.&#xD;
&#xD;
          -  Elective PCI was defined as any coronary revascularization in a low-risk patient who&#xD;
             presents to the facility for a planned PCI or for a coronary angiogram followed by ad&#xD;
             hoc PCI.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Patients were excluded from the study if the patient has&#xD;
&#xD;
          1. Any procedural complication included:&#xD;
&#xD;
               -  prolonged chest pain,&#xD;
&#xD;
               -  transient coronary artery closure, no-flow or slow-flow phenomenon,&#xD;
&#xD;
               -  hemodynamic instability,&#xD;
&#xD;
               -  persistent electrocardiographic changes,&#xD;
&#xD;
               -  side-branch occlusion of &gt;1.5 mm, or&#xD;
&#xD;
               -  an angiographically suboptimal result,&#xD;
&#xD;
          2. Arterial access other than the right or left femoral artery ,&#xD;
&#xD;
          3. Vascular perforation, thrombosis during procedure ,&#xD;
&#xD;
          4. Patients with high risk of puncture site complications as:&#xD;
&#xD;
               -  Bleeding diathesis,&#xD;
&#xD;
               -  International normalized ratio &gt;1.5,&#xD;
&#xD;
               -  Recent thrombolysis,&#xD;
&#xD;
               -  Low platelet count,&#xD;
&#xD;
               -  Hematoma at the end of the procedure,&#xD;
&#xD;
               -  Previous iliofemoral artery surgery or any peripheral vascular Surgery,&#xD;
&#xD;
               -  Previous femoral artery complication from angiography, and&#xD;
&#xD;
          5. Uncontrolled hypertension at time of procedure (&gt;180/&gt;110).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ayman K.M. Hassan, MD. PhD.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Assiut University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Assiut University Hospitals</name>
      <address>
        <city>Assiut</city>
        <zip>71526</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Hassan AKM, Hasan-Ali H, Ali AS. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal. 2013 (in-press).</citation>
  </reference>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>July 26, 2014</study_first_submitted>
  <study_first_submitted_qc>August 9, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 12, 2014</study_first_posted>
  <last_update_submitted>July 14, 2021</last_update_submitted>
  <last_update_submitted_qc>July 14, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Ayman khairy Mohamed</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>Femoral compression device</keyword>
  <keyword>manual compression</keyword>
  <keyword>arterial hemostasis</keyword>
  <keyword>coronary intervention</keyword>
  <keyword>coronary artery disease</keyword>
  <!-- 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/NCT02214030
org study id: AFCD-03
secondary id: AUH-03
nct id: NCT02214030
lead sponsor: 
has dmc: Yes
This study was performed to evaluate the safety and efficacy of a locally designed Assiut
      Femoral Compression Device (AFCD) versus manual compression (MC). Femoral compression devices
      have been developed thorough the past decades without being strongly implemented in the
      catheterization laboratory. Their limited adoption reflects concerns of high cost and
      conflicting data regarding their safety
The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the
      standard local protocols. However for AFCD group, the sheaths were removed 2 hours after PCI
      instead of conventional 6 hours. To standardize compression times, AFCD were applied to
      patient and complete femoral artery compression were applied for 5 minutes, followed by a
      gradual release of pressure till distal pulse is palpated. Each patient received a minimum of
      13 minutes of compression, with further compression applied only if full hemostasis had not
      been achieved at that point with maximum of 30 minutes.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Time-To-Ambulation (TTA), measured in hours
time frame: TTA was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to time of ambulation
description: Ambulation was defined as patient standing and walking at least 6 meters (20 feet) without re-bleeding or significant oozing requiring manual compression
measure: the absence of major adverse events on discharge
time frame: 24 post procedure
description: major adverse event (MAE) was defined as symptomatic bleeding associated with hemoglobin drop ≥5 g/dL requiring blood transfusion, fatal bleeding that directly results in death, a pseudoaneurysm or arteriovenous fistula, distal arterial embolism, infections requiring administration of IV antibiotics or debridement, and the need for vascular surgery.
measure: Device success:
time frame: 5 minutes during application
description: This was defined as easy application of the device with good fixation and stability and achieving final hemostasis. Device Stability was defined as absence of tilt and/or mobility after application of the device on top of the patient groin. Assessment of the device application was performed using a questionnaire with a scale of three grades; "Easy", "Difficult" and "Requires Improvement". Assessment of stability and fixation of the device was performed on a scale defined as "Very Good", "Good" and "Bad".
measure: Procedure success
time frame: 24 h post procedure
description: This was defined as hemostasis achieved by the assigned method, without the occurrence of a closure-related major adverse event (MAE).
measure: Time-To-Hemostasis (TTH), measured in minutes.
time frame: TTH was measured from the time the introducer sheath was removed (2 hr in AFCD group and 6 hours in MC group after end of PCI) to the time hemostasis was achieved
description: Hemostasis was defined as no or minimal subcutaneous oozing and the absence of expanding or developing hematoma
measure: Minor complications:
time frame: 24h post procedure
description: Any oozing (leakage of blood from the puncture site requiring digital pressure), ecchymosis (bleeding into subcutaneous tissue planes causing bluish-purple discoloration > 4cm in diameter), hematoma (non pulsatile mass > 1 cm in diameter), and infections treatable with oral antibiotics
measure: Patient discomfort:
time frame: within 10 minutes of device application
description: was assessed based on a short form of the McGill Pain Questionnaire using a Present Pain Intensity (PPI) scale that rated pain from 0 (no pain) to 5 (excruciating).
measure: Vasovagal manifestations
time frame: within 10 minutes of device application
description: (sweating, bradycardia, nausea and vomiting) were recorded.
measure: Time the patient is deemed eligible for hospital discharge
time frame: within 24 hours post procedure
description: Time the patient is deemed eligible for hospital discharge based on the report of the attending resident
arm group label: Assiut Femoral Compression Device
arm group type: Active Comparator
description: the sheaths were removed 2 hours after PCI instead of conventional 6hours. To standardize compression times, AFCD were applied to patient and complete femoral artery compression were applied for 5 minutes, followed by a gradual release of pressure over the ensuing 8 minutes. Therefore each patient received a minimum of 13 minutes of compression, with further compression applied only if full hemostasis had not been achieved at that point with maximum of 30 minutes.
arm group label: Manual compression
arm group type: Placebo Comparator
description: The intra-arterial sheaths were removed 6 hours after PCI in the MC group according to the standard local protocols.
intervention type: Device
intervention name: Assiut Femoral Compression Device
description: Assiut Femoral Compression Devices (AFCD) is a femoral compression system, The pressure dome is situated over the vessel puncture site in the groin and applies a mechanical pressure over the vessel puncture site to induce hemostasis.
arm group label: Assiut Femoral Compression Device
arm group label: Manual compression
other name: AFCD
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ayman K.M. Hassan, MD. PhD.
role: Principal Investigator
affiliation: Assiut University
facility: 
country: Egypt
citation: Hassan AKM, Hasan-Ali H, Ali AS. A new femoral compression device compared with manual compression for bleeding control after coronary diagnostic catheterizations. The Egyptian Heart Journal. 2013 (in-press).
responsible party type: Principal Investigator
investigator affiliation: Assiut University
investigator full name: Ayman khairy Mohamed
investigator title: Dr.