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

NCT02759406 | Completed

• 1 other identifier: Mach-5
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (4)

• late lumen loss rate by Quantative/ Qualtative Cornary Angiographia

  6 month

• total percentage of strut coverage by Optical Coherence Tomography analysis

  6 month

• Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices.

  6 month

• binary restenosis rate by Quantative/ Qualtative Cornary Angiographia

  6 month

Study Arms (2)

Mach-5 Grooved

EXPERIMENTAL

grooved

Device: coronary stent

Mach 5 Bare Metal

EXPERIMENTAL

bare metal

Device: coronary stent

Interventions

coronary stent DEVICE

Mach 5 Bare Metal; Mach-5 Grooved

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Palmaz Scientific: lead
• ClinLogix. LLC: collaborator

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 3, 2016
• Study Start: September 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: May 3, 2016

Record last verified: 2016-04