Rotational Atherectomy Prior to Taxus Stent

Segeberger Kliniken GmbH

Status and phase: Completed; Phase 4

Conditions: Complex Calcified Coronary Lesions

Treatments: Procedure: Standard Treatment (PES without Rotational Atherectomy); Procedure: Rotational Atherectomy + PES

Study type: Interventional

Funder types: Other

Identifiers

NCT00380809

SK 106

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 240 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

240 participants in 2 patient groups

Rotational Atherectomy + PES

Active Comparator group

Description:

Elective lesion preparation with rotational atherectomy priot to stent implantation

Treatment:

Procedure: Rotational Atherectomy + PES

Standard Treatment (PES without Rotational Atherectomy)

Active Comparator group

Description:

Stenting without prior rotational atherectomy, usually preceeded with balloon dilatation

Treatment:

Procedure: Standard Treatment (PES without Rotational Atherectomy)