Clinical trial NCT01701596: Safety and Efficacy of Rotational Atherectomy (RA) in Coronary Dissection
Official title: Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Coronary Artery Disease
Keywords: Rotational atherectomy
Coronary dissection
Percutaneous coronary intervention
Calcification
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2012-10-05
Enrollment: 198
Sex: ALL
Minimum age (years): 30
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: All cause death
timeFrame: 4 years
Secondary outcomes:
measure: Left ventricular ejection fraction (LVEF)
timeFrame: 4 years
measure: 6-min walk distance (6MWD)
timeFrame: 4 years
measure: angina class
timeFrame: 4 years
measure: Non-fatal myocardial infarction
timeFrame: 4 years
measure: Stent thrombosis
timeFrame: 4 years
measure: Cardiac tamponade
timeFrame: 4 years
measure: Stroke
timeFrame: 4 years
measure: Target lesion revascularization
timeFrame: 4 years
measure: New York Heart Association (NYHA) class IV heart failure
timeFrame: 4 years
Other outcomes:
Locations:
city: Xi'an
country: China
facility: Xijing Hospital, Fourth Military Medical University
state: Shaanxi
Study officials:
affiliation: Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
name: Chengxiang Li, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: