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Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study

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ClinicalTrials.gov Identifier: NCT02759406
Recruitment Status : Completed
First Posted : May 3, 2016
Last Update Posted : May 3, 2016
Sponsor:
Collaborator:
ClinLogix. LLC
Information provided by (Responsible Party):
Palmaz Scientific

Tracking Information
First Submitted Date  ICMJE April 27, 2016
First Posted Date  ICMJE May 3, 2016
Last Update Posted Date May 3, 2016
Study Start Date  ICMJE September 2013
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 28, 2016)
  • late lumen loss rate by Quantative/ Qualtative Cornary Angiographia [ Time Frame: 6 month ]
  • total percentage of strut coverage by Optical Coherence Tomography analysis [ Time Frame: 6 month ]
  • Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices. [ Time Frame: 6 month ]
  • binary restenosis rate by Quantative/ Qualtative Cornary Angiographia [ Time Frame: 6 month ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study
Official Title  ICMJE Evaluation of the Palmaz Mach-5 Grooved Bare Metal Coronary Stent System Versus the Palmaz Bare Metal Coronary Stent System in Patients With Symptomatic Ischemic Heart Disease: A Safety and Performance Study
Brief Summary This is a six (6) month, randomized, un-blinded, study to assess the safety and performance of the Palmaz Mach-5 Grooved Coronary Stent System vs. the Palmaz Bare Metal Coronary Stent System.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Ischemic Heart Disease
Intervention  ICMJE Device: coronary stent
Study Arms  ICMJE
  • Experimental: Mach-5 Grooved
    grooved
    Intervention: Device: coronary stent
  • Experimental: Mach 5 Bare Metal
    bare metal
    Intervention: Device: coronary stent
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 28, 2016)
48
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2015
Actual Primary Completion Date May 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female patients of any race greater than or equal to 18 years and of legal consent
  2. Patients must be willing to comply with the specified follow-up evaluation schedule
  3. Patients who sign an informed consent (signed and dated) prior to any study-related evaluation or procedure.
  4. Patients who are willing to undergo a follow-up coronary angiogram and Endovascular Imaging via Optical Coherence Tomography
  5. Patients willing to be maintained on Aspirin and Clopidogrel bisulfate (Plavix) for ninety (90) days post procedure.
  6. Patients with a de novo coronary lesion causing angina and/or a positive function test
  7. Patients who are eligible for percutaneous coronary interventions
  8. Low risk NSTEMI defined as patients with ACS, unstable angina, positive cardiac biomarkers and hemodynamically stable as assessed by the Investigator.
  9. Patients with an acceptable risk for coronary bypass graft surgery (CABG)

Intra-Procedure Angiographic Criteria:

  1. Single de novo target lesion >50% diameter stenosis by angiography
  2. Single target vessel 2.75 to 3.25 mm diameter
  3. Lesion length of 14 to 20mm which is suitable for Palmaz Mach-5 Grooved Coronary Stent System or the Palmaz Bare Metal Coronary Stent System.

Exclusion Criteria:

  1. Known allergy or sensitivity to cobalt chromium (CoCr) alloy or its components.
  2. Known sensitivity or allergy to aspirin, radiographic contract agents (that cannot be pre-treated adequately).
  3. Patients unable to tolerate anticoagulant therapy or antiplatelet therapy.
  4. History of bleeding or known coagulopathy.
  5. Patients with thrombocytopenia and or neutropenia.
  6. More than one stenosis >50% in target vessel.
  7. Lesion in aortic ostium.
  8. Left main or LAD, CX lesions within 2-mm from the origin.
  9. Ejection Fraction <45%.
  10. STEMI in evolution.
  11. Disabling stroke within previous 30 days.
  12. Patients currently enrolled in another Investigational device or drug study.
  13. Previous enrollment in this study.
  14. Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required within 24 hours of procedure.)
  15. Known or suspected active systemic infection.
  16. Evidence of severe or uncontrolled systemic diseases, including chronic renal insufficiency, or any condition which in the Investigator's opinion makes it undesirable for the patient to participate in the trial or which would jeopardize compliance with the protocol.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02759406
Other Study ID Numbers  ICMJE Mach-5
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Palmaz Scientific
Study Sponsor  ICMJE Palmaz Scientific
Collaborators  ICMJE ClinLogix. LLC
Investigators  ICMJE Not Provided
PRS Account Palmaz Scientific
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP