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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Xijing Hospital
ClinicalTrials.gov Identifier:
NCT01701596
First received: September 28, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

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 Intervention Phase
Coronary Artery Disease
Procedure: Immediate rotational atherectomy (RA)
Procedure: Delayed rotational atherectomy (RA)
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Safety and Efficacy of Immediate Rotational Atherectomy in Nondilatable Calcified Lesion Complicated by Coronary Dissection (RAISE)

Further study details as provided by Xijing Hospital:

Primary Outcome Measures:
  • All cause death [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
    cardiac death and non-cardiac death


Secondary Outcome Measures:
  • Left ventricular ejection fraction (LVEF) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • 6-min walk distance (6MWD) [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • angina class [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire

  • Non-fatal myocardial infarction [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stent thrombosis [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Cardiac tamponade [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Stroke [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • Target lesion revascularization [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]
  • New York Heart Association (NYHA) class IV heart failure [ Time Frame: 4 years ] [ Designated as safety issue: Yes ]

Enrollment: 198
Study Start Date: August 2004
Study Completion Date: June 2013
Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 85 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01701596

Locations
China, Shaanxi
Xijing Hospital, Fourth Military Medical University
Xi'an, Shaanxi, China, 710032
Sponsors and Collaborators
Xijing Hospital
Investigators
Principal Investigator: Chengxiang Li, M.D., Ph.D. Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
  More Information

No publications provided

Responsible Party: Xijing Hospital
ClinicalTrials.gov Identifier: NCT01701596     History of Changes
Other Study ID Numbers: RAISE
Study First Received: September 28, 2012
Last Updated: August 18, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Xijing Hospital:
Rotational atherectomy
Coronary dissection
Percutaneous coronary intervention
Calcification

Additional relevant MeSH terms:
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Arterial Occlusive Diseases
Arteriosclerosis
Cardiovascular Diseases
Heart Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014