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

Study Overview
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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.

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.

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

Conditions
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Coronary Artery Disease

Intervention / Treatment
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* Procedure: Immediate rotational atherectomy (RA)
* Procedure: Delayed rotational atherectomy (RA)


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rotational atherectomy (RA)<br>Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection | Procedure: Immediate rotational atherectomy (RA)<br>* Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.<br>|
| Active Comparator: Delayed rotational atherectomy (RA)<br>Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection | Procedure: Delayed rotational atherectomy (RA)<br>* Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All cause death | cardiac death and non-cardiac death | 4 years | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification