Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)
1 other identifier
interventional
3
1 country
1
Brief Summary
Non-randomized, single arm, multi-center, clinical trial evaluating the Corio™ pimecrolimus-eluting stent with reduced anti-platelet therapy in patients with de novo lesions of the native coronary arteries.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2006
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2006
CompletedFirst Submitted
Initial submission to the registry
May 4, 2006
CompletedFirst Posted
Study publicly available on registry
May 8, 2006
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2008
CompletedOctober 17, 2008
September 1, 2008
6 months
May 4, 2006
October 16, 2008
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Angiographic endpoint of in-stent late lumen loss at 6 months
6 months
Secondary Outcomes (2)
Major Adverse Cardiac Events (MACE) defined as an adjudicated composite of clinically driven target vessel revascularization, new myocardial infarction (MI) or cardiac death at 30 days, 6 months, 12 months and 2 years;
30 days, 6 months, 12 months and 2 years
Device, Lesion and Procedural Success; Coronary angiography at 6 months; IVUS measurements in IVUS cohort at 6 months.
6 months
Study Arms (1)
Drug eluting stent
EXPERIMENTALCorio™ Pimecrolimus-eluting stent
Interventions
Eligibility Criteria
You may qualify if:
- Eligible for percutaneous coronary intervention (PCI).
- Documented stable or unstable angina pectoris
- Left ventricular ejection fraction (LVEF) ≥25%
- Acceptable candidate for coronary artery bypass graft surgery (CABG).
- Target Lesion \< 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of \>= 50 and \< 100 %.
You may not qualify if:
- Known sensitivity to pimecrolimus, the polymer (PLGA) or cobalt chromium.
- Planned treatment with any other PCI device in the target vessel(s).
- MI within 72 hours prior to the index procedure
- The patient is in cardiogenic shock.
- Cerebrovascular Accident (CVA) within the past 6 months.
- Acute or chronic renal dysfunction
- Contraindication to ASA or to clopidogrel.
- Thrombocytopenia
- Active gastrointestinal (GI) bleeding within the past 3 months.
- Any prior true anaphylactiod reaction to contrast agents
- Patient is currently taking chronic systemic steroid therapy or systemic immunosuppressant therapy or topical pimecrolimus.
- Female of childbearing potential.
- Life expectancy of less than 24 months due to other medical conditions.
- Co-morbid condition(s)
- Currently participating in another investigational drug or device study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Conor Medsystemslead
Study Sites (1)
Institute Dante Pazzanese of Cardiology
São Paulo, São Paulo, 04012-180, Brazil
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alexandre Abizaid, M.D.
Institute Dante Pazzanese of Cardiology
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
May 4, 2006
First Posted
May 8, 2006
Study Start
May 1, 2006
Primary Completion
November 1, 2006
Study Completion
May 1, 2008
Last Updated
October 17, 2008
Record last verified: 2008-09