Rotational Atherectomy Prior to Taxus Stent

Study Overview
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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.

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.

Official Title
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Rotational Atherectomy Prior to Taxus Stent Treatment for Complex Native Coronary Artery Disease. A Multicenter, Prospective, Randomized Controlled Trial.

Conditions
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Complex Calcified Coronary Lesions

Intervention / Treatment
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* Procedure: Rotational Atherectomy + PES
* Procedure: Standard Treatment (PES without Rotational Atherectomy)


Participation Criteria
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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 Angiographic exclusion criteria: Unprotected left main lesions Coronary artery bypass graft stenoses In-stent restenoses Chronic total occlusions Target vessel thrombus Target vessel dissection

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rotational Atherectomy + PES<br>Elective lesion preparation with rotational atherectomy priot to stent implantation | Procedure: Rotational Atherectomy + PES<br> <br> |
| Active Comparator: Standard Treatment (PES without Rotational Atherectomy)<br>Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation | Procedure: Standard Treatment (PES without Rotational Atherectomy)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-stent late lumen loss |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events (MACE) |  | 9 months | 
| In-segment late lumen loss |  | 9 months | 
| In-segment binary restenosis |  | 9 months | 
| Primary angiographic success |  | Immediate | 
| Procedural duration and contrast dye amount |  | Immediate | 
| Strategy success |  | Immediate |