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

Coronary Artery Disease Clinical Trial

Official title:

Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01701596
• Other study ID #: RAISE
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: September 28, 2012
• Last updated: August 18, 2014
• Start date: August 2004
• Est. completion date: June 2013

Study information

• Verified date: August 2014
• Source: Xijing Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 198
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Procedure:
• Immediate rotational atherectomy (RA)
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

Locations

Country	Name	City	State
China	Xijing Hospital, Fourth Military Medical University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xijing Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All cause death	cardiac death and non-cardiac death	4 years	Yes
Secondary	Left ventricular ejection fraction (LVEF)		4 years	No
Secondary	6-min walk distance (6MWD)		4 years	No
Secondary	angina class	angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire	4 years	No
Secondary	Non-fatal myocardial infarction		4 years	Yes
Secondary	Stent thrombosis		4 years	Yes
Secondary	Cardiac tamponade		4 years	Yes
Secondary	Stroke		4 years	Yes
Secondary	Target lesion revascularization		4 years	Yes
Secondary	New York Heart Association (NYHA) class IV heart failure		4 years	Yes