<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/NCT03271177</url>
  </required_header>
  <id_info>
    <org_study_id>2016-04</org_study_id>
    <nct_id>NCT03271177</nct_id>
  </id_info>
  <brief_title>Ultrasound Comparison of Radial Artery Hyperplasia After Use of a 7F Sheathless Guide vs. 6F Sheath/Guide Combination</brief_title>
  <acronym>PRAGMATIC</acronym>
  <official_title>The PRAGMATIC Study:A Prospective Randomized Clinical Trial Comparing Radial Artery Intimal Hyperplasia Resulting From a 7F Sheathless Guide (Mach 1TM) vs. a 6F Transradial Sheath/Guide Combination in Coronary Intervention</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tallahassee Research Institute, Inc.</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Boston Scientific Corporation</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Tallahassee Research Institute, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to determine if the routine use of a sheathless 7F guide&#xD;
      catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F&#xD;
      sheath/guide combination with regards to radial artery injury (radial artery&#xD;
      intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution&#xD;
      ultrasonography (55 mHz) will be used to accurately quantify radial artery&#xD;
      intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority&#xD;
      analysis will be performed to compare the degree of radial artery IMT at 90 days between the&#xD;
      7F sheathless guide approach and the 6F sheath/guide combination.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The purpose of the PRAGMATIC study (A Prospective Randomized Trial comparing Radial Artery&#xD;
      Intimal Hyperplasia resulting from a 7F Transradial Sheathless Guide [Mach 1] vs. a 6F&#xD;
      Transradial Sheath/Guide Combination in Coronary Intervention) is 3 fold: (1) to determine if&#xD;
      the routine use of a simple inexpensive &quot;home-made&quot; 7F sheathless guide catheter approach for&#xD;
      TRA-PCI was associated with comparable degrees of radial artery access site injury and&#xD;
      intimal-medial thickening (IMT) as the routine use of a 6F standard sheath/guide catheter&#xD;
      combination; (2) to determine if the 7F sheathless approach was associated with comparable&#xD;
      procedural success rates, procedure times, number of guides and crossover rates to a femoral&#xD;
      approach compared to a 6F sheath/guide combination; and (3) to use ultrahigh resolution&#xD;
      ultrasound to characterize the degree of RA injury and intimal-medial hyperplasia (IMT) that&#xD;
      routinely occurs following transradial percutaneous coronary intervention.&#xD;
&#xD;
      Materials and Methods&#xD;
&#xD;
      Subjects and Study Design The study enrolled 41 consecutive patients undergoing elective&#xD;
      non-emergent TRA-PCI at Tallahassee Memorial Hospital (TMH) from June 2016 to December 2016.&#xD;
      The study protocol was approved by the TMH institutional review board. Informed consent was&#xD;
      obtained prior to diagnostic coronary arteriography. Patients aged 21 years and over who were&#xD;
      undergoing planned non-emergent PCI and willing to undergo a 24 hour and 90day post PCI RA&#xD;
      ultrasound were eligible. Patients were excluded if they had undergone a prior ipsilateral&#xD;
      TRA heart catheterization or PCI. There were no angiographic exclusions. Baseline clinical,&#xD;
      demographic and angiographic characteristics were collected prospectively. Patients were&#xD;
      randomly assigned to undergo TRA-PCI using a 7F sheathless Mach 1TM (Boston Scientific,&#xD;
      Marlborough, MA) guide catheter or using our catheterization lab's standard 6F CordisTM&#xD;
      (Johnson and Johnson, Inc.) sheath/6F Mach1TM guide combination. In order to minimize radial&#xD;
      artery size bias, randomization was stratified according to patient sex. PCI with a&#xD;
      drug-eluting stent was performed according to routine local practice and physician&#xD;
      discretion. Patients were preferentially treated with a SYNERGYTM (Boston Scientific,&#xD;
      Marlborough, MA) drug-eluting stent as the primary stent choice, however, other stents were&#xD;
      allowed according to physician discretion.&#xD;
&#xD;
      All patients received dual antiplatelet therapy (DAPT) prior to TRA-PCI with an oral aspirin&#xD;
      (325 mg) and a p2Y12 platelet inhibitor (either 600mg clopidogrel or 180mg ticagrelor) bolus.&#xD;
      Intravenous heparin was administered to achieve an activated clotting time (ACT) of at least&#xD;
      300 seconds. Immediately following TRA-PCI, the sheath and/or guide was removed and RA&#xD;
      hemostasis was achieved using a standardized and previously validated patent hemostasis&#xD;
      protocol that incorporates the Terumo TR Band Radial Compression DeviceTM.&#xD;
&#xD;
      The technique used for the sheathless introduction of the 7F guide catheter was as follows:&#xD;
      following diagnostic coronary angiography, a 6F 100 cm length multipurpose catheter (MP) was&#xD;
      telescoped through the inner lumen of a 90 cm 7F Mach 1TM guide catheter. The MP was then&#xD;
      used as an obturator to facilitate insertion of the 7F guide through the skin and into the RA&#xD;
      arteriotomy site over a 0.035 J wire. Only after the 7F guide/6F MP combination was&#xD;
      introduced into the RA and advanced together back to the aortic root, were the inner 6F MP&#xD;
      catheter and 0.035 wire removed and the 7F guide engaged into the coronary ostium for&#xD;
      TRA-PCI.&#xD;
&#xD;
      Ultrahigh Resolution Ultrasound Assessment Using the FDA approved FUJIFILM VisualSonics 55&#xD;
      mHz probe and previously established methods,16,17 ultrahigh resolution duplex ultrasound of&#xD;
      the RA access site was performed at 24 hours (pre-discharge) and 90 days post TRA-PCI. This&#xD;
      technique has been well validated as a means to accurately depict and quantify the individual&#xD;
      layers of muscular and elastic arteries. To prevent RA vasospasm, sublingual nitroglycerin&#xD;
      (0.4 mg) was administered within 3-5 minutes prior to performing the ultrasound studies.&#xD;
      M-mode, 2-dimensional and color doppler images were obtained. The RA diameter was recorded&#xD;
      and then the individual borders of the layers of the artery delineated with M-mode&#xD;
      ultrasound. To determine the mean IMT, we started off with the center of the probe centered&#xD;
      over the RA puncture site and recorded the thickest IMT measurements noted just proximal to&#xD;
      the site, at the center of the site (center of probe) and just distal to the site. We then&#xD;
      repositioned the probe more proximally, placing its distal leading edge at the puncture site&#xD;
      and obtained another proximal and mid probe measurement of IMT. The final recorded IMT was&#xD;
      the average of these 5 measurements. Using this technique, we ensured sampling over an&#xD;
      adequate length of the RA proximal to, at and slightly distal to the point of arterial&#xD;
      access.&#xD;
&#xD;
      The RA access site was also assessed for other signs of trauma, including small focal intimal&#xD;
      tears, frank arterial dissections, pseudoaneurysms, arteriovenous fistulae, and vessel&#xD;
      occlusion. Given high resolution imaging, we were forced to distinguish between limited focal&#xD;
      intimal tears that were now easily visualized and simply a result of access site entry from&#xD;
      more frank dissections. For this, we defined a limited access site intimal tear (LASIT) as a&#xD;
      focal tear in the intima that was restricted to and not beyond the access site itself which&#xD;
      did not encroach on the lumen or cause any flow abnormality. Tears or dissections beyond this&#xD;
      were deemed true dissections. All studies and measurements were performed by 2 experienced&#xD;
      vascular technicians who were blinded to treatment allocation with additional independent&#xD;
      review by a reading physician who was also blinded to treatment allocation.&#xD;
&#xD;
      Other Clinical Endpoints Assessed:&#xD;
&#xD;
      Procedural success rates (successful implantation of the stent with residual stenosis of &lt;&#xD;
      30% and no other complications), fluoroscopy time, the number of guide catheters used, and&#xD;
      the frequency of cross-over from radial access to femoral access were also recorded. Routine&#xD;
      clinical and interventional outcomes, including PCI success, in-hospital death, MI, coronary&#xD;
      dissection, urgent revascularization were also prospectively collected. Ultrahigh frequency&#xD;
      ultrasound parameters related&#xD;
&#xD;
      Statistical Analysis For comparisons between groups, two-sided Student t-tests were used for&#xD;
      continuous variables and chi-square or Fisher exact tests for discrete variables. The primary&#xD;
      outcome of the study was a comparison of radial artery IMT thickness at 90 days between the&#xD;
      7F sheathless guide catheter group and the standard 6F sheath/guide combination group. The&#xD;
      primary statistical analysis was based on a non-inferiority analysis and an intention to&#xD;
      treat design. The null hypothesis was that the 7F sheathless Mach 1TM guide would be&#xD;
      associated with at least a 0.08mm increase in IMT at 90 days compared with the 6F&#xD;
      sheath/guide combination. A non-inferiority margin of 0.08 mm was selected as this&#xD;
      represented a relatively small change compared to baseline IMT and RA diameter (~25% of&#xD;
      baseline IMT and only ~3% of RA diameter). It was therefore deemed unlikely that this small&#xD;
      difference would be clinically significant. Based on our own pilot data and a prior study, a&#xD;
      standard deviation of 0.08mm was assumed for IMT measurements. Assuming a one-sided 95%&#xD;
      confidence interval, at least 36 evaluated patients (~18 per group) were needed to have 90%&#xD;
      power to detect if the lower limit of the one-sided confidence interval lies above the 0.08&#xD;
      limit. If the 95% confidence interval lies below this 0.08mm boundary, then the null&#xD;
      hypothesis was to be rejected and non-inferiority declared. Superiority testing was also&#xD;
      applied using a p&lt;0.05 for a level of significance for intergroup comparisons.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 25, 2016</start_date>
  <completion_date type="Actual">March 13, 2017</completion_date>
  <primary_completion_date type="Actual">March 13, 2017</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>Radial artery access site intimal-medial thickness (IMT)</measure>
    <time_frame>90-day</time_frame>
    <description>The incidence of other vascular complications such as radial artery occlusion, pseudo-aneurysms, radial artery diameter, and radial artery dissections will also be assessed.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Procedural Success Rate</measure>
    <time_frame>up to 24 hours</time_frame>
    <description>Procedural Success Rate (successful coronary stent implantation with &lt; 30% residual stenosis and no other complications)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Major Adverse Cardiac Events (MACE)</measure>
    <time_frame>from date of PCI until date of death, MI or urgent revascularization, whichever came first, assessed up to 72 hrs</time_frame>
    <description>In-hospital MACE (death, MI, urgent revascularization)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Fluoroscopy Time</measure>
    <time_frame>During PCI procedure (from beginning of procedure until end)</time_frame>
    <description>Fluoroscopy Time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Guide Catheters Used</measure>
    <time_frame>During PCI procedure (from beginning of procedure until end)</time_frame>
    <description>Number of Guide Catheters Used during the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Frequency of Cross-over from Radial Access to Femoral Access</measure>
    <time_frame>During PCI procedure (from beginning of procedure until end)</time_frame>
    <description>Rate of Needing to Cross-over from Radial Access to Femoral Access</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">41</enrollment>
  <condition>Coronary Artery Disease</condition>
  <arm_group>
    <arm_group_label>7F Sheathless Guide Catheter</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this arm will undergo their percutaneous coronary intervention using a 7F Sheathless guide catheter</description>
  </arm_group>
  <arm_group>
    <arm_group_label>6F Sheath/Guide Catheter Combination</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Patients in this arm will undergo their percutaneous coronary intervention using a 6F Sheath/guide combination</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>7F sheathless Guide Catheter</intervention_name>
    <description>Transradial PCI will be performed with a 7F sheathless Guide Catheter</description>
    <arm_group_label>7F Sheathless Guide Catheter</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>6F Sheath/Guide Catheter Combination</intervention_name>
    <description>Transradial PCI will be performed with a 6F Sheath/Guide Catheter Combination</description>
    <arm_group_label>6F Sheath/Guide Catheter Combination</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 18 or above with coronary artery disease&#xD;
&#xD;
          -  Scheduled for transradial PCI&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Has had prior transradial access for heart catheterization or PCI in same radial&#xD;
             artery as planned access site&#xD;
&#xD;
          -  Not willing to undergo follow-up ultrasound examinations&#xD;
&#xD;
          -  Acute ST elevation myocardial infarction or other emergent PCI&#xD;
&#xD;
          -  Inability to provide informed consent&#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>Wayne B Batchelor, MD, MHS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tallahassee Research Institute</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 23, 2017</study_first_submitted>
  <study_first_submitted_qc>August 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 1, 2017</study_first_posted>
  <last_update_submitted>August 31, 2017</last_update_submitted>
  <last_update_submitted_qc>August 31, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>transradial percutaneous coronary intervention</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronary Artery Disease</mesh_term>
    <mesh_term>Hyperplasia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03271177
org study id: 2016-04
nct id: NCT03271177
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to determine if the routine use of a sheathless 7F guide
      catheter for transradial percutaneous coronary intervention (TR PCI) is non-inferior to a 6F
      sheath/guide combination with regards to radial artery injury (radial artery
      intimal-medial-adventitial thickening). To evaluate the radial artery, ultrahigh resolution
      ultrasonography (55 mHz) will be used to accurately quantify radial artery
      intimal-medial-adventitial thickness (IMT) at baseline and 90 days. A non-inferiority
      analysis will be performed to compare the degree of radial artery IMT at 90 days between the
      7F sheathless guide approach and the 6F sheath/guide combination.
The purpose of the PRAGMATIC study (A Prospective Randomized Trial comparing Radial Artery
      Intimal Hyperplasia resulting from a 7F Transradial Sheathless Guide [Mach 1] vs. a 6F
      Transradial Sheath/Guide Combination in Coronary Intervention) is 3 fold: (1) to determine if
      the routine use of a simple inexpensive "home-made" 7F sheathless guide catheter approach for
      TRA-PCI was associated with comparable degrees of radial artery access site injury and
      intimal-medial thickening (IMT) as the routine use of a 6F standard sheath/guide catheter
      combination; (2) to determine if the 7F sheathless approach was associated with comparable
      procedural success rates, procedure times, number of guides and crossover rates to a femoral
      approach compared to a 6F sheath/guide combination; and (3) to use ultrahigh resolution
      ultrasound to characterize the degree of RA injury and intimal-medial hyperplasia (IMT) that
      routinely occurs following transradial percutaneous coronary intervention.

      Materials and Methods

      Subjects and Study Design The study enrolled 41 consecutive patients undergoing elective
      non-emergent TRA-PCI at Tallahassee Memorial Hospital (TMH) from June 2016 to December 2016.
      The study protocol was approved by the TMH institutional review board. Informed consent was
      obtained prior to diagnostic coronary arteriography. Patients aged 21 years and over who were
      undergoing planned non-emergent PCI and willing to undergo a 24 hour and 90day post PCI RA
      ultrasound were eligible. Patients were excluded if they had undergone a prior ipsilateral
      TRA heart catheterization or PCI. There were no angiographic exclusions. Baseline clinical,
      demographic and angiographic characteristics were collected prospectively. Patients were
      randomly assigned to undergo TRA-PCI using a 7F sheathless Mach 1TM (Boston Scientific,
      Marlborough, MA) guide catheter or using our catheterization lab's standard 6F CordisTM
      (Johnson and Johnson, Inc.) sheath/6F Mach1TM guide combination. In order to minimize radial
      artery size bias, randomization was stratified according to patient sex. PCI with a
      drug-eluting stent was performed according to routine local practice and physician
      discretion. Patients were preferentially treated with a SYNERGYTM (Boston Scientific,
      Marlborough, MA) drug-eluting stent as the primary stent choice, however, other stents were
      allowed according to physician discretion.

      All patients received dual antiplatelet therapy (DAPT) prior to TRA-PCI with an oral aspirin
      (325 mg) and a p2Y12 platelet inhibitor (either 600mg clopidogrel or 180mg ticagrelor) bolus.
      Intravenous heparin was administered to achieve an activated clotting time (ACT) of at least
      300 seconds. Immediately following TRA-PCI, the sheath and/or guide was removed and RA
      hemostasis was achieved using a standardized and previously validated patent hemostasis
      protocol that incorporates the Terumo TR Band Radial Compression DeviceTM.

      The technique used for the sheathless introduction of the 7F guide catheter was as follows:
      following diagnostic coronary angiography, a 6F 100 cm length multipurpose catheter (MP) was
      telescoped through the inner lumen of a 90 cm 7F Mach 1TM guide catheter. The MP was then
      used as an obturator to facilitate insertion of the 7F guide through the skin and into the RA
      arteriotomy site over a 0.035 J wire. Only after the 7F guide/6F MP combination was
      introduced into the RA and advanced together back to the aortic root, were the inner 6F MP
      catheter and 0.035 wire removed and the 7F guide engaged into the coronary ostium for
      TRA-PCI.

      Ultrahigh Resolution Ultrasound Assessment Using the FDA approved FUJIFILM VisualSonics 55
      mHz probe and previously established methods,16,17 ultrahigh resolution duplex ultrasound of
      the RA access site was performed at 24 hours (pre-discharge) and 90 days post TRA-PCI. This
      technique has been well validated as a means to accurately depict and quantify the individual
      layers of muscular and elastic arteries. To prevent RA vasospasm, sublingual nitroglycerin
      (0.4 mg) was administered within 3-5 minutes prior to performing the ultrasound studies.
      M-mode, 2-dimensional and color doppler images were obtained. The RA diameter was recorded
      and then the individual borders of the layers of the artery delineated with M-mode
      ultrasound. To determine the mean IMT, we started off with the center of the probe centered
      over the RA puncture site and recorded the thickest IMT measurements noted just proximal to
      the site, at the center of the site (center of probe) and just distal to the site. We then
      repositioned the probe more proximally, placing its distal leading edge at the puncture site
      and obtained another proximal and mid probe measurement of IMT. The final recorded IMT was
      the average of these 5 measurements. Using this technique, we ensured sampling over an
      adequate length of the RA proximal to, at and slightly distal to the point of arterial
      access.

      The RA access site was also assessed for other signs of trauma, including small focal intimal
      tears, frank arterial dissections, pseudoaneurysms, arteriovenous fistulae, and vessel
      occlusion. Given high resolution imaging, we were forced to distinguish between limited focal
      intimal tears that were now easily visualized and simply a result of access site entry from
      more frank dissections. For this, we defined a limited access site intimal tear (LASIT) as a
      focal tear in the intima that was restricted to and not beyond the access site itself which
      did not encroach on the lumen or cause any flow abnormality. Tears or dissections beyond this
      were deemed true dissections. All studies and measurements were performed by 2 experienced
      vascular technicians who were blinded to treatment allocation with additional independent
      review by a reading physician who was also blinded to treatment allocation.

      Other Clinical Endpoints Assessed:

      Procedural success rates (successful implantation of the stent with residual stenosis of <
      30% and no other complications), fluoroscopy time, the number of guide catheters used, and
      the frequency of cross-over from radial access to femoral access were also recorded. Routine
      clinical and interventional outcomes, including PCI success, in-hospital death, MI, coronary
      dissection, urgent revascularization were also prospectively collected. Ultrahigh frequency
      ultrasound parameters related

      Statistical Analysis For comparisons between groups, two-sided Student t-tests were used for
      continuous variables and chi-square or Fisher exact tests for discrete variables. The primary
      outcome of the study was a comparison of radial artery IMT thickness at 90 days between the
      7F sheathless guide catheter group and the standard 6F sheath/guide combination group. The
      primary statistical analysis was based on a non-inferiority analysis and an intention to
      treat design. The null hypothesis was that the 7F sheathless Mach 1TM guide would be
      associated with at least a 0.08mm increase in IMT at 90 days compared with the 6F
      sheath/guide combination. A non-inferiority margin of 0.08 mm was selected as this
      represented a relatively small change compared to baseline IMT and RA diameter (~25% of
      baseline IMT and only ~3% of RA diameter). It was therefore deemed unlikely that this small
      difference would be clinically significant. Based on our own pilot data and a prior study, a
      standard deviation of 0.08mm was assumed for IMT measurements. Assuming a one-sided 95%
      confidence interval, at least 36 evaluated patients (~18 per group) were needed to have 90%
      power to detect if the lower limit of the one-sided confidence interval lies above the 0.08
      limit. If the 95% confidence interval lies below this 0.08mm boundary, then the null
      hypothesis was to be rejected and non-inferiority declared. Superiority testing was also
      applied using a p<0.05 for a level of significance for intergroup comparisons.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Radial artery access site intimal-medial thickness (IMT)
time frame: 90-day
description: The incidence of other vascular complications such as radial artery occlusion, pseudo-aneurysms, radial artery diameter, and radial artery dissections will also be assessed.
measure: Procedural Success Rate
time frame: up to 24 hours
description: Procedural Success Rate (successful coronary stent implantation with < 30% residual stenosis and no other complications)
measure: Major Adverse Cardiac Events (MACE)
time frame: from date of PCI until date of death, MI or urgent revascularization, whichever came first, assessed up to 72 hrs
description: In-hospital MACE (death, MI, urgent revascularization)
measure: Fluoroscopy Time
time frame: During PCI procedure (from beginning of procedure until end)
description: Fluoroscopy Time
measure: Number of Guide Catheters Used
time frame: During PCI procedure (from beginning of procedure until end)
description: Number of Guide Catheters Used during the procedure
measure: Frequency of Cross-over from Radial Access to Femoral Access
time frame: During PCI procedure (from beginning of procedure until end)
description: Rate of Needing to Cross-over from Radial Access to Femoral Access
arm group label: 7F Sheathless Guide Catheter
arm group type: Experimental
description: Patients in this arm will undergo their percutaneous coronary intervention using a 7F Sheathless guide catheter
arm group label: 6F Sheath/Guide Catheter Combination
arm group type: Placebo Comparator
description: Patients in this arm will undergo their percutaneous coronary intervention using a 6F Sheath/guide combination
intervention type: Device
intervention name: 7F sheathless Guide Catheter
description: Transradial PCI will be performed with a 7F sheathless Guide Catheter
arm group label: 7F Sheathless Guide Catheter
intervention type: Device
intervention name: 6F Sheath/Guide Catheter Combination
description: Transradial PCI will be performed with a 6F Sheath/Guide Catheter Combination
arm group label: 6F Sheath/Guide Catheter Combination
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Wayne B Batchelor, MD, MHS
role: Principal Investigator
affiliation: Tallahassee Research Institute
responsible party type: Sponsor
mesh term: Coronary Artery Disease
mesh term: Hyperplasia
sharing ipd: No