Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease

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

UNKNOWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Brief Summary

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The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary intervention.

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Detailed Description

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Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Bx Sonic & Cypher stent from Cordis

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* Stable, or unstable angina and/or objective signs of myocardial ischaemia
* Informed consent
* Optimal result (\< 35% residual stenosis and \< type C dissection) after balloon angioplasty
* Lesions should be de novo and located in native vessels with a diameter \> 2.25 mm.
* Complex lesions to be included should have at least one of the following characteristics:

* ostial in location (\< 5 mm from ostium)
* total occlusions with a length ≥ 15 mm
* bifurcational (side branch \> 1.75 mm in diameter)
* angulated (\> 45° within lesion)

Exclusion Criteria

Patients:

* Other severe disease with an expected survival \< 1 year
* Other significant cardiac disease
* Known allergy against paclitaxel, clopidogrel (or ticlopidine),
* Myocardial infarction within 3 days of the index procedure
* Linguistic difficulties needing an interpreter
* Renal insufficiency (p-creatinine \> 200 micromol/l)
* Gastrointestinal bleeding within 1 month
* Childbearing potential or pregnancy
* Participation in another study

Lesions:

* Unprotected left main disease
* Restenosis
* Lesions containing visible thrombus
* Treatment with other modality than balloon or stent (ablation, brachytherapy, ultrasound) in connection with the index procedure
* Diffuse coronary disease distal to the treated lesion
* Heavily calcification
* Lesion located in saphenous vein graft

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No