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

April 28, 2016 updated by: Palmaz Scientific
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
48

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Mach-5 Grooved
grooved
Device: coronary stent
Experimental: Mach 5 Bare Metal
bare metal
Device: coronary stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
late lumen loss rate by Quantative/ Qualtative Cornary Angiographia
Time Frame: 6 month
6 month
total percentage of strut coverage by Optical Coherence Tomography analysis
Time Frame: 6 month
6 month
Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices.
Time Frame: 6 month
6 month
binary restenosis rate by Quantative/ Qualtative Cornary Angiographia
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Palmaz Scientific

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ClinLogix. LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 27, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 3, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 28, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • Mach-5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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