A Randomized, Multi-Center, Single-Blind Comparison of the Conor Cobalt Chromium Reservoir Based Stent with Sirolimus-Elution versus the TAXUS Liberte Paclitaxel-Eluting Coronary Stent System in De Novo Native Coronary Artery Lesions

A Multi-Center, Randomized Evaluation of Treatment Outcomes in Patients with De Novo Coronary Atherosclerotic Lesions Treated with the Conor Sirolimus-eluting Coronary Stent System compared to the TAXUS Liberte Paclitaxel-eluting Coronary System Assessed by Angiographic Late Loss at Six Months

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12608000196347

Acronym

The RES-ELUTION Study

Enrollment

388

Registered

2008-04-14

Start date

2008-03-21

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The purpose of the study is to evaluate the safety and efficacy of the Conor Sirolimus-eluting Coronary Stent System in the treatment of coronary artery disease. The study will evaluate the outcomes of a new drug-eluting stent compared to an approved drug-eluting stent.

Interventions

Percutaneous coronary intervention for treatment of a single coronary lesion with implantation of a Conor Sirolimus-eluting Coronary Stent. The coronary stenting procedure can take from one to two hours while the stent is a permanent implant.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

The subject is eligible for percutaneous coronary intervention and coronary artery bypass graft surgery, The subject has a diagnosis of stable or unstable angina, or silent ischemia, The subject has a left ventricular ejection fraction >30%, The subject requires treatment of a single de novo lesion in a native coronary artery, The subject understands the study requriements, is willing to comply with all study procedures and has provided written informed consent.

Exclusion criteria

The subject has undergone prior coronary artery bypass graft surgery, prior coronary brachytherapy, prior coronary stent implant to the target vessel, prior coronary intervention within 30 days, or prior revascularization to the target vessel within the previous 6 months. The subject has experienced recent myocardial infarction within 72 hours. The subject has experienced a cerebrovascular accident within the last 6 months, active gastrointestinal bleeding within the last 3 months, has a known bleeding disorder, hypercoagulable disorder or thrombocytopenia. The subject is a female of childbearing potential with a positive pregnancy test or is lactating. The subject has co-morbidities that could interfere with completion of study procedures, or life expectancy less than 24 months.

Outcome results