A Study of the Cypher SES to Treat Restenotic Native Coronary Artery Lesions.

Cordis US Corp.162 enrolled

Overview

The main objective of this study is to assess the safety and effectiveness of the Cypher™ sirolimus-eluting stent in reducing angiographic in-lesion late loss in patients with an in-stent restenotic native coronary artery lesion.

This is a multicenter (11 sites), non-randomized study. Patients who meet the eligibility criteria will be treated with the Cypher™ sirolimus-eluting stent. All patients will have a repeat angiography at six months post-procedure and will be additionally followed clinically at 1, 6 and 9 months and up to 3 years. The results of this study will be compared with the outcome of the GAMMA I / II as the historical control.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

162

Conditions

Coronary Artery Disease

Interventions

drug-eluting stentDEVICE

PCI

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The patient has an in-stent restenosis of ≥ 60% and \< 100% (by QCA online of the MLD compared to the distal reference diameter) in a native coronary artery. 2. The study target lesion can not be located in a vessel containing another lesion requiring treatment. Lesions located in other vessels may be treated with percutaneous revascularization at the time of the procedure, BUT they must be successfully treated prior to the treatment of the study target lesion. Exclusion Criteria: 1. Unprotected left main coronary disease with ≥ 50% stenosis; 2. Patient previously treated with brachytherapy in any coronary vessel. 3. Target lesion involves bifurcation including a side branch \>2.5mm in diameter. 4. The patient sustained a recent (\<72 hours) myocardial infarction defined as a serum CK 2x the upper limit of normal and elevated MB or abnormal lab values.

Locations (2)

K.U. Leuven

Leuven, Belgium

Herz-zentrum Bad Krozingen

Bad Krozingen, Germany

Outcomes

Primary Outcomes

angiographic in-lesion late loss

Time frame: 6 months post-procedure

Secondary Outcomes

in-stent mean percent diameter stenosis (%DS)

Time frame: 6-months post-procedure

i-stent late loss (LL)

Time frame: 6 months post-procedure

in-lesion binary restenosis

Time frame: 6-months post-procedure

Target Vessel Revascularization (TVR)

Time frame: 9-months post-procedure

Target Vessel Failure (TVF) defined as any revascularization of the index vessel or myocardial infarction or death that cannot be clearly attributed to a vessel other than the index vessel

Time frame: 9 months post-procedure

Composite of Major Adverse Cardiac Events (MACE) defined as death, myocardial infarction (Q wave and non-Q wave), emergent bypass surgery, or repeat target lesion revascularization in-hospital

Time frame: 1, 6, 9 months and, 2 and 3 years post-procedure

occurrence of bleeding

Time frame: 1, 6, 9 months and, 2 and 3 years post-procedure

Data from ClinicalTrials.gov

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