Ischemic Heart DiseaseNCT02759406
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
A study testing coronary stent in people with Ischemic Heart Disease, run by Palmaz Scientific.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ischemic Heart Disease
- What is being tested?
- coronary stent
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- No sites listed yet
- Study dates
- Sep 2013to Jun 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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.
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- 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.
About this study
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
- Being tested
- coronary stent
- Medical subject headings
- Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
coronary stentDevice
| Study group | Role | What they receive |
|---|---|---|
| Mach-5 Grooved | Experimental | grooved Receives: Device: coronary stent |
| Mach 5 Bare Metal | Experimental | bare metal Receives: Device: coronary stent |
What is being measured
The primary outcome is the main question the study is designed to answer.
late lumen loss rate by Quantative/ Qualtative Cornary Angiographia
Measured: 6 month
total percentage of strut coverage by Optical Coherence Tomography analysis
Measured: 6 month
Primary safety endpoint is the occurrence of adverse events associated with the Investigational and comparator devices.
Measured: 6 month
binary restenosis rate by Quantative/ Qualtative Cornary Angiographia
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startSep 2013
- Primary completionMay 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ischemic Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Palmaz Scientific
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759406
- Sponsor's protocol ID
- Mach-5
- Status last verified
- Apr 2016
- First submitted
- 27 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02759406
- Acronym / sponsor ID
- Mach-5
- Conditions
- Ischemic Heart Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Palmaz ScientificIndustry (pharma, biotech, devices)
- Collaborators
- ClinLogix. LLC
- Study start
- Sep 2013
- Primary completion
- May 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 3 May 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mach-5 Grooved | Experimental | Device: coronary stentgrooved |
| Mach 5 Bare Metal | Experimental | Device: coronary stentbare metal |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| coronary stent | Device | Mach 5 Bare Metal, Mach-5 Grooved |
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing coronary stent in people with Ischemic Heart Disease, run by Palmaz Scientific.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
late lumen loss rate by Quantative/ Qualtative Cornary Angiographia (time frame: 6 month). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2016.