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The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries | Clinical Trials | Clareo Health

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The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

NCT01025869•Atrium Medical Corporation

View on ClinicalTrials.gov

Summary

To investigate the safety and efficacy of the Cinatra™ Corolimus Drug Eluting Stent for the treatment of de novo lesions in native coronary arteries.

Detailed Description

This is a single-arm, multicentre pilot study designed to provide an indication of the effectiveness and safety of the Cinatra™ Corolimus Eluting Coronary Stent System. The primary endpoint to be evaluated in this study is late lumen loss (in-stent) at 6 months post-procedure as measured by QCA in the 30 participants undergoing angiography at this timepoint. Late lumen loss is defined as the difference between the post-index procedure minimal lumen diameter (MLD) and the follow-up MLD.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is ≥ 18 years old
•2. Patient is an acceptable candidate for percutaneous coronary intervention (PCI), stenting, and emergent coronary artery bypass graft (CABG) surgery
•3. Patient has clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia, and/or a positive functional study
•4. Female subjects of childbearing potential must have a negative pregnancy test within 7 days before the trial procedure
•5. Patient or subject's legal representative has been informed of the nature of the trial and agrees to its provisions and has provided written informed consent as approved by the Hospital Research Ethics Committee (HREC) of the respective investigational site
•6. Patient agrees to comply with specified follow-up evaluations and to return to the same investigational site where the procedure was performed
•Angiographic:
•1. Patient has either a single target lesion, or two lesions (target and non-target) located in separate coronary arteries
•2. If a non-target lesion is treated, it must be treated first and only with commercially available PTCA balloons and/or stents. Post PCI of the non-target vessel, all of the following conditions must be met:
•* Residual diameter stenosis \<10%
+8 more criteria

Exclusion Criteria

•1. Known hypersensitivity or contraindication to aspirin, heparin or bivalirudin, clopidogrel or ticlopidine, cobalt, chromium, stent coatings (i.e. fatty acids, glycerides, and alpha tocopherol), or a sensitivity to contrast media, which cannot be adequately pre-medicated
•2. History of an allergic reaction or significant sensitivity to drugs such as , zotarolimus, rapamycin, tacrolimus, everolimus, or any other analogue or derivative
•3. Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³ within 7 days prior to index procedure
•4. Serum creatinine level 170 micromol/L within 7 days prior to index procedure
•5. Evidence of an acute myocardial infarction (MI) within 72 hours of the intended trial procedure (defined as: Q wave myocardial infarction (QWMI) or non-Q wave myocardial infarction (NQWMI) having CK enzymes \> 2X the laboratory upper limit of normal with the presence of an elevated CK-MB (any amount above the laboratory upper limit of normal)
•6. Previous PCI of the target vessel within 9 months prior to the procedure
•7. Any planned additional PCI procedure within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
•8. During the index procedure, the target and/or non-target lesion(s) requires treatment with a device other than PTCA prior to stent placement (including, but not limited to, cutting balloon, atherectomy, thrombectomy, etc.)
•9. Left ventricular ejection fraction (LVEF) \< 30% if evaluated, or clinical evidence of significant congestive heart failure (NYHA Class III or IV) within the prior 30 days
•10. History of a stroke or transient ischemic attack (TIA) within the prior 6 months
+17 more criteria

Locations (4)

Auckland City Hospital

Auckland, New Zealand

Mercy Angiography

Auckland, New Zealand

North Shore Hospital

Auckland, New Zealand

Christchurch Hospital

Christchurch, New Zealand

Key Dates

Start Date

December 1, 2009

Primary Completion Date

November 1, 2010

Completion Date

March 1, 2012

Last Updated

January 12, 2016

Enrollment

ACTUAL participants

Conditions

Coronary Artery Disease

Interventions

Cinatra™ Corolimus Eluting Coronary Stent System

DEVICE

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Coronary Artery Disease

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RECRUITING

"Erectile Function After PCI in MI and Non-MI Patients"

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Erectile DisfunctionCoronary Artery Disease (CAD)+3 more

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 12, 2016Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

The Clinical Evaluation of the Cinatra™ Corolimus-Eluting Coronary Stent in De Novo Lesions in Native Coronary Arteries

Inclusion Criteria

Exclusion Criteria

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