Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection

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

PHASE1/PHASE2

Total Enrollment

198 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-08-31

Study Completion Date

2013-06-30

Brief Summary

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This study is aimed at examining the safety and efficacy of rotational atherectomy (RA) in nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure.

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Detailed Description

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Coronary artery dissection is a contraindication for the use of rotational atherectomy, since rotational atherectomy may propagate coronary dissection. In the presence of coronary dissection, conservative management is suggested for approximately 4 weeks to permit the dissection to heal prior to treatment with rotational atherectomy. However, a lot of patients have frequent angina attacks and some patients develop serious complications including abrupt vessel closure during this period. Thus, immediate strategies cope with coronary dissection induced by balloon dilation is needed for the early recovery of those patients. The present study was performed to compare the safety and efficacy of immediate RA and delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

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

Study Groups

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Rotational atherectomy (RA)

Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection

Group Type EXPERIMENTAL

Immediate rotational atherectomy (RA)

Intervention Type PROCEDURE

Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Delayed rotational atherectomy (RA)

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Group Type ACTIVE_COMPARATOR

Delayed rotational atherectomy (RA)

Intervention Type PROCEDURE

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Interventions

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Immediate rotational atherectomy (RA)

Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.

Intervention Type PROCEDURE

Delayed rotational atherectomy (RA)

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* age between 30 and 85 years old
* nondilatable calcified lesion complicated by coronary dissection during percutaneous coronary intervention (PCI) procedure
* Coronary artery dissection type A, B and type C according to the National Heart, Lung and Blood Institute (NHLBI) coronary dissection criteria

Exclusion Criteria

* acute myocardial infarction
* unprotected left main stenosis
* chronic total occlusion
* saphenous vein graft lesion
* cardiomyopathy
* severe valvular heart disease
* NYHA functional class IV heart failure at baseline
* chronic renal failure on hemodialysis
* severe lung and liver disease or cancer

Minimum Eligible Age

30 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No