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
Primary Purpose
Ischemic Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
coronary stent
Sponsored by
About this trial
This is an interventional treatment trial for Ischemic Heart Disease
Eligibility Criteria
Inclusion Criteria:
- Male or female patients of any race greater than or equal to 18 years and of legal consent
- Patients must be willing to comply with the specified follow-up evaluation schedule
- Patients who sign an informed consent (signed and dated) prior to any study-related evaluation or procedure.
- Patients who are willing to undergo a follow-up coronary angiogram and Endovascular Imaging via Optical Coherence Tomography
- Patients willing to be maintained on Aspirin and Clopidogrel bisulfate (Plavix) for ninety (90) days post procedure.
- Patients with a de novo coronary lesion causing angina and/or a positive function test
- Patients who are eligible for percutaneous coronary interventions
- Low risk NSTEMI defined as patients with ACS, unstable angina, positive cardiac biomarkers and hemodynamically stable as assessed by the Investigator.
- Patients with an acceptable risk for coronary bypass graft surgery (CABG)
Intra-Procedure Angiographic Criteria:
- Single de novo target lesion >50% diameter stenosis by angiography
- Single target vessel 2.75 to 3.25 mm diameter
- 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:
- Known allergy or sensitivity to cobalt chromium (CoCr) alloy or its components.
- Known sensitivity or allergy to aspirin, radiographic contract agents (that cannot be pre-treated adequately).
- Patients unable to tolerate anticoagulant therapy or antiplatelet therapy.
- History of bleeding or known coagulopathy.
- Patients with thrombocytopenia and or neutropenia.
- More than one stenosis >50% in target vessel.
- Lesion in aortic ostium.
- Left main or LAD, CX lesions within 2-mm from the origin.
- Ejection Fraction <45%.
- STEMI in evolution.
- Disabling stroke within previous 30 days.
- Patients currently enrolled in another Investigational device or drug study.
- Previous enrollment in this study.
- Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required within 24 hours of procedure.)
- Known or suspected active systemic infection.
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Mach-5 Grooved
Mach 5 Bare Metal
Arm Description
grooved
bare metal
Outcomes
Primary Outcome Measures
late lumen loss rate by Quantative/ Qualtative Cornary Angiographia
total percentage of strut coverage by Optical Coherence Tomography analysis
Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices.
binary restenosis rate by Quantative/ Qualtative Cornary Angiographia
Secondary Outcome Measures
Full Information
NCT ID
NCT02759406
First Posted
April 27, 2016
Last Updated
April 28, 2016
Sponsor
Palmaz Scientific
Collaborators
ClinLogix. LLC
1. Study Identification
Unique Protocol Identification Number
NCT02759406
Brief Title
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
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
June 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Palmaz Scientific
Collaborators
ClinLogix. LLC
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ischemic Heart Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mach-5 Grooved
Arm Type
Experimental
Arm Description
grooved
Arm Title
Mach 5 Bare Metal
Arm Type
Experimental
Arm Description
bare metal
Intervention Type
Device
Intervention Name(s)
coronary stent
Primary Outcome Measure Information:
Title
late lumen loss rate by Quantative/ Qualtative Cornary Angiographia
Time Frame
6 month
Title
total percentage of strut coverage by Optical Coherence Tomography analysis
Time Frame
6 month
Title
Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices.
Time Frame
6 month
Title
binary restenosis rate by Quantative/ Qualtative Cornary Angiographia
Time Frame
6 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male or female patients of any race greater than or equal to 18 years and of legal consent
Patients must be willing to comply with the specified follow-up evaluation schedule
Patients who sign an informed consent (signed and dated) prior to any study-related evaluation or procedure.
Patients who are willing to undergo a follow-up coronary angiogram and Endovascular Imaging via Optical Coherence Tomography
Patients willing to be maintained on Aspirin and Clopidogrel bisulfate (Plavix) for ninety (90) days post procedure.
Patients with a de novo coronary lesion causing angina and/or a positive function test
Patients who are eligible for percutaneous coronary interventions
Low risk NSTEMI defined as patients with ACS, unstable angina, positive cardiac biomarkers and hemodynamically stable as assessed by the Investigator.
Patients with an acceptable risk for coronary bypass graft surgery (CABG)
Intra-Procedure Angiographic Criteria:
Single de novo target lesion >50% diameter stenosis by angiography
Single target vessel 2.75 to 3.25 mm diameter
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:
Known allergy or sensitivity to cobalt chromium (CoCr) alloy or its components.
Known sensitivity or allergy to aspirin, radiographic contract agents (that cannot be pre-treated adequately).
Patients unable to tolerate anticoagulant therapy or antiplatelet therapy.
History of bleeding or known coagulopathy.
Patients with thrombocytopenia and or neutropenia.
More than one stenosis >50% in target vessel.
Lesion in aortic ostium.
Left main or LAD, CX lesions within 2-mm from the origin.
Ejection Fraction <45%.
STEMI in evolution.
Disabling stroke within previous 30 days.
Patients currently enrolled in another Investigational device or drug study.
Previous enrollment in this study.
Women who are currently pregnant. (A negative pregnancy test for female subjects of child bearing potential is required within 24 hours of procedure.)
Known or suspected active systemic infection.
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.
12. IPD Sharing Statement
Learn more about this trial
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
We'll reach out to this number within 24 hrs