Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID)

Reduced Anti-Platelet Therapy With Pimecrolimus Drug Eluting Stent (RAPID) A Multi-Center Study of the Pimecrolimus-Eluting Cobalt Chromium Coronary Stent System (Corio™) in Patients With De Novo Lesions of the Native Coronary Arteries

Status

Terminated

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00322543

Enrollment

Registered

2006-05-08

Start date

2006-05-31

Completion date

2008-05-31

Last updated

2008-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Disease

Keywords

Percutaneous coronary intervention (PCI), Drug eluting stent (DES)

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.

Detailed description

The registry is designed to evaluate 6-month in-stent late lumen loss in patients receiving the Corio™ drug-eluting stent.

Interventions

DEVICECorio™ Pimecrolimus-eluting stent

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

General Inclusion Criteria 1. Eligible for percutaneous coronary intervention (PCI). 2. Documented stable or unstable angina pectoris 3. Left ventricular ejection fraction (LVEF) ≥25% 4. Acceptable candidate for coronary artery bypass graft surgery (CABG). 5. Target Lesion \< 25 mm in length with RVD of 2.5 to 3.5 mm with visually estimated stenosis of \>= 50 and \< 100 %.

Exclusion criteria

General

Design outcomes

Primary

Measure	Time frame
Angiographic endpoint of in-stent late lumen loss at 6 months	6 months

Secondary

Measure	Time frame
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

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026