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

NCT ID: NCT00232856

Last Updated: 2008-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

162 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-12-31

Study Completion Date

2006-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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1

Cypher™ sirolimus-eluting stent

Group Type OTHER

drug-eluting stent

Intervention Type DEVICE

PCI

Interventions

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drug-eluting stent

PCI

Intervention Type DEVICE

Other Intervention Names

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Cypher™ sirolimus-eluting stent

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cordis Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Cordis

Principal Investigators

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Franz-Josef Neumann, MD

Role: PRINCIPAL_INVESTIGATOR

Herz-zentrum Bad Krozingen

Walter Desmet, MD

Role: PRINCIPAL_INVESTIGATOR

K.U. Leuven

Locations

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K.U. Leuven

Leuven, , Belgium

Site Status

Herz-zentrum Bad Krozingen

Bad Krozingen, , Germany

Site Status

Countries

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Belgium Germany

Other Identifiers

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EC01-06

Identifier Type: -

Identifier Source: org_study_id