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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
Immediate rotational atherectomy (RA)
Delayed rotational atherectomy (RA)
Sponsored by
Xijing Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification

Eligibility Criteria

30 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Xijing Hospital, Fourth Military Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Rotational atherectomy (RA)

Delayed rotational atherectomy (RA)

Arm Description

Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection

Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection

Outcomes

Primary Outcome Measures

All cause death
cardiac death and non-cardiac death

Secondary Outcome Measures

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

Full Information

First Posted
September 28, 2012
Last Updated
August 18, 2014
Sponsor
Xijing Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01701596
Brief Title
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

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Xijing Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Rotational atherectomy, Coronary dissection, Percutaneous coronary intervention, Calcification

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
198 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rotational atherectomy (RA)
Arm Type
Experimental
Arm Description
Immediate rotational atherectomy (RA) in the treatment with nondilatable calcified lesion complicated by coronary dissection
Arm Title
Delayed rotational atherectomy (RA)
Arm Type
Active Comparator
Arm Description
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
Intervention Type
Procedure
Intervention Name(s)
Immediate rotational atherectomy (RA)
Intervention Description
Immediate RA in the treatment with nondilatable calcified lesion complicated by coronary dissection.
Intervention Type
Procedure
Intervention Name(s)
Delayed rotational atherectomy (RA)
Intervention Description
Delayed RA in the treatment with nondilatable calcified lesion complicated by coronary dissection
Primary Outcome Measure Information:
Title
All cause death
Description
cardiac death and non-cardiac death
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Left ventricular ejection fraction (LVEF)
Time Frame
4 years
Title
6-min walk distance (6MWD)
Time Frame
4 years
Title
angina class
Description
angina class according to the Canadian Cardiovascular Society (CCS) classification and Seattle Angina Questionnaire
Time Frame
4 years
Title
Non-fatal myocardial infarction
Time Frame
4 years
Title
Stent thrombosis
Time Frame
4 years
Title
Cardiac tamponade
Time Frame
4 years
Title
Stroke
Time Frame
4 years
Title
Target lesion revascularization
Time Frame
4 years
Title
New York Heart Association (NYHA) class IV heart failure
Time Frame
4 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chengxiang Li, M.D., Ph.D.
Organizational Affiliation
Department of Cardiolody, Xijing Hospital, Fourth Military Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Xijing Hospital, Fourth Military Medical University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710032
Country
China

12. IPD Sharing Statement

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

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