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

NCT ID: NCT02759406

Last Updated: 2016-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2015-06-30

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.

Conditions

Ischemic Heart Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mach-5 Grooved

grooved

Group Type: EXPERIMENTAL

coronary stent

Intervention Type: DEVICE

Mach 5 Bare Metal

bare metal

Group Type: EXPERIMENTAL

coronary stent

Intervention Type: DEVICE

Interventions

coronary stent

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

ClinLogix. LLC

INDUSTRY

Sponsor Role: collaborator

Palmaz Scientific

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

Mach-5

Identifier Type: -

Identifier Source: org_study_id