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

Phase 1

Completed

• Conditions: Coronary Artery Disease
• Interventions: Procedure: Immediate rotational atherectomy (RA); Procedure: Delayed rotational atherectomy (RA)

• Registration Number: NCT01701596
• Lead Sponsor: Xijing Hospital

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2004-08
• Study First Submitted: 2012-09-28
• Study First Submitted QC: 2012-10-03
• Study First Posted: 2012-10-05
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 198

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rotational atherectomy (RA)	Immediate rotational atherectomy (RA)	Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection
Delayed rotational atherectomy (RA)	Delayed rotational atherectomy (RA)	Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Primary Outcome Measures

Name	Time	Method
All cause death	4 years	cardiac death and non-cardiac death

Secondary Outcome Measures

Name	Time	Method
Left ventricular ejection fraction (LVEF)	4 years
Stent thrombosis	4 years
New York Heart Association (NYHA) class IV heart failure	4 years
Non-fatal myocardial infarction	4 years
Cardiac tamponade	4 years
Stroke	4 years
6-min walk distance (6MWD)	4 years
angina class	4 years	angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
Target lesion revascularization	4 years

Trial Locations

Locations (1)

Xijing Hospital, Fourth Military Medical University; 🇨🇳 Xi'an, Shaanxi, China