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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01701596
Recruitment Status : Completed
First Posted : October 5, 2012
Last Update Posted : August 20, 2014
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Coronary Artery Disease Procedure: Immediate rotational atherectomy (RA) Procedure: Delayed rotational atherectomy (RA) Phase 1 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 198 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)
Study Start Date : August 2004
Actual Primary Completion Date : June 2013
Actual Study Completion Date : June 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Rotational atherectomy (RA)
Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection
 Procedure: Immediate rotational atherectomy (RA)
Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
Active Comparator: Delayed rotational atherectomy (RA)
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
 Procedure: Delayed rotational atherectomy (RA)
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection


Outcome Measures
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Primary Outcome Measures :
  1. All cause death [ Time Frame: 4 years ]
    cardiac death and non-cardiac death


Secondary Outcome Measures :
  1. Left ventricular ejection fraction (LVEF) [ Time Frame: 4 years ]
  2. 6-min walk distance (6MWD) [ Time Frame: 4 years ]
  3. angina class [ Time Frame: 4 years ]
    angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire

  4. Non-fatal myocardial infarction [ Time Frame: 4 years ]
  5. Stent thrombosis [ Time Frame: 4 years ]
  6. Cardiac tamponade [ Time Frame: 4 years ]
  7. Stroke [ Time Frame: 4 years ]
  8. Target lesion revascularization [ Time Frame: 4 years ]
  9. New York Heart Association (NYHA) class IV heart failure [ Time Frame: 4 years ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01701596


Locations
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China, Shaanxi
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
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Principal Investigator: Chengxiang Li, M.D., Ph.D. Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
More Information
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Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01701596    
Other Study ID Numbers: RAISE
First Posted: October 5, 2012    Key Record Dates
Last Update Posted: August 20, 2014
Last Verified: August 2014
Keywords provided by Xijing Hospital:
Rotational atherectomy
Coronary dissection
Percutaneous coronary intervention
Calcification
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases