Rotational Atherectomy Prior to Taxus Stent

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

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-08-31

Study Completion Date

2011-05-31

Brief Summary

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The primary purpose of this study is to evaluate the long term effects of the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions.

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Detailed Description

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Calcification is an essential part of all atherosclerotic plaques. Its extent increases with the progression of atherosclerotic disease. Heavily calcified lesions form a particular threat to DES; both damage to the polymer coating during vigorous advancement and inadequate diffusion of the drug to the subintima through extensive calcium arcs could contribute to the ineffectiveness of DES when implanted into such lesions, or may lead to primary stent delivery or expansion failure. Rotational atherectomy can effectively ablate calcified plaques. In the DES era, data concerning rotational atherectomy are scarce. DES implantation following rotablation seems a rational combination, but is only poorly supported by controlled studies. In the present study, we are using the polymer-based slow-release paclitaxel-eluting stent (TAXUS; Boston Scientific), with or without prior rotablation, in an angiographically well defined group of patients with complex calcified coronary lesions. This prospective, randomized, controlled study aims at evaluating the long term effects of both strategies in this complex cohort of patients.

Conditions

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Complex Calcified Coronary Lesions

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Rotational Atherectomy + PES

Elective lesion preparation with rotational atherectomy priot to stent implantation

Group Type ACTIVE_COMPARATOR

Rotational Atherectomy + PES

Intervention Type PROCEDURE

Standard Treatment (PES without Rotational Atherectomy)

Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation

Group Type ACTIVE_COMPARATOR

Standard Treatment (PES without Rotational Atherectomy)

Intervention Type PROCEDURE

Interventions

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Rotational Atherectomy + PES

Intervention Type PROCEDURE

Standard Treatment (PES without Rotational Atherectomy)

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Angiographically proven coronary artery disease
* Angina II-IV° following the Canadian Cardiovascular Society Classification criteria and/or reproducible ischemia in the target area by ECG or scintigraphy
* The patient signing an informed written consent

From the following angiographic criteria, lesions must fulfil all first degree criteria and at least one second-degree criterion to be eligible for inclusion.

First degree criteria

* De-novo lesion in a native coronary artery
* Target reference vessel diameter between 2.5 and 4.0 mm by visual estimation
* Luminal diameter reduction of 70-99% by visual estimation
* Moderate to severe calcification of the target lesion (clearly defined)

Second degree criteria

* Ostial location
* Bifurcational lesions
* Long lesions (≥ 15mm)

Exclusion Criteria

* Myocardial infarction within 4 weeks
* Left ventricular ejection fraction \< 30%
* Limited long term prognosis due to other conditions

* Unprotected left main lesions
* Coronary artery bypass graft stenoses
* In-stent restenoses
* Chronic total occlusions
* Target vessel thrombus
* Target vessel dissection

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No