Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries (REVASC)
Primary Purpose
Coronary Heart Disease
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
revascularisation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Heart Disease focused on measuring chronic occlusion of coronary artery, left ventricular function, revascularisation
Eligibility Criteria
Inclusion Criteria:
- chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
- chronic total occlusion has more than 4 weeks duration
- the target vessel has not previously been treated with percutaneous coronary intervention
- the target vessel must be feasible for stent implantation
- patient has stable or unstable angina pectoris or a positive functional study for ischemia
- patient must be 18 years of age or older
- female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
- patient has been informed of the nature of the study and agrees to its
- provisions ans has written informed consent as approved by the Ethics Committee
- patient complies with all required post-procedure follow-up
Exclusion Criteria:
- a documented left ventricular function < 30%
- patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
- patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
- patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
- patient has a history of bleeding diathesis or coagulopathy
- patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
- active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
- patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
- the target vessel contains intraluminal thrombus
- the target vessel or lesson shows angiographic evidence of severe calcification
- patient has contraindications to magnetic resonance imaging
Sites / Locations
- Universitäts Herzzentrum Freiburg Bad Krozingen
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Active Comparator
Arm Label
medical therapy
revascularisation
Arm Description
patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.
revascularisation and stent-implantation of chronic occluded coronary artery
Outcomes
Primary Outcome Measures
Changes from baseline in regional left ventricular function at 9 months
Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.
Secondary Outcome Measures
Change from baseline in global left ventricular function at 6 months
Improvement of global left ventricular function (assessed by magnetic resonance imaging at baseline and 9 months post-procedure. For global left ventricular analysis, all short-axis slices from the apex to the base will be assessed. By planimetry of all short-axis views, left ventricular end-systolic volume (in milliliters), left ventricular end-diastolic volume (in milliliters), and ejection fraction (in percent) will be determined.
Changes from baseline in left ventricular volume at 6 months
Changes in diastolic and systolic volume indices (assessed by magnetic resonance imaging at baseline and 9 months post-procedure)
Full Information
NCT ID
NCT01924962
First Posted
August 15, 2013
Last Updated
November 3, 2017
Sponsor
University Heart Center Freiburg - Bad Krozingen
1. Study Identification
Unique Protocol Identification Number
NCT01924962
Brief Title
Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries
Acronym
REVASC
Official Title
A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 28, 2008 (Actual)
Primary Completion Date
August 14, 2016 (Actual)
Study Completion Date
June 16, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Heart Center Freiburg - Bad Krozingen
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study is a randomised comparison of recanalisation of chronic occluded coronary arteries with implantation of Sirolimus eluting stents and medical therapy. Myocardial function and scar-size are determinated by using magnetic resonance imaging. The study hypothesis is the superiority of medical therapy over revascularisation.
Detailed Description
In the REVASC-study recovery of left ventricular function after recanalization of chronic total coronary occlusions (CTO) and implantation of sirolimus-eluting stents will be examined and compared to medical treatment. Extent of the scar, viable myocardium in the infarct zone and regional left ventricular function will be assessed by cardiac magnetic resonance. Patients with regional systolic left ventricular dysfunction of any degree in the supply territory of the CTO vessel will be randomized to either recanalization of the occluded coronary artery or to conservative therapy. It is of interest whether CTO patients will have an improvement in left ventricular function after late coronary reopening, regarding the high technical demands and costs of CTO recanalization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Heart Disease
Keywords
chronic occlusion of coronary artery, left ventricular function, revascularisation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
205 (Actual)
8. Arms, Groups, and Interventions
Arm Title
medical therapy
Arm Type
No Intervention
Arm Description
patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.
Arm Title
revascularisation
Arm Type
Active Comparator
Arm Description
revascularisation and stent-implantation of chronic occluded coronary artery
Intervention Type
Device
Intervention Name(s)
revascularisation
Other Intervention Name(s)
Cypher-stent
Intervention Description
revascularisation of chronic occluded coronary artery
Primary Outcome Measure Information:
Title
Changes from baseline in regional left ventricular function at 9 months
Description
Improvement of the left ventricular function in the territory of the chronically occluded coronary artery assessed by magnetic resonance imaging before revascularisation and at 9 months post-procedure. For regional left ventricular analysis, wall thickening and systolic inward motion will be determined in 12 segments in all short axis slices by the modified centerline method.
Time Frame
9 months
Secondary Outcome Measure Information:
Title
Change from baseline in global left ventricular function at 6 months
Description
Improvement of global left ventricular function (assessed by magnetic resonance imaging at baseline and 9 months post-procedure. For global left ventricular analysis, all short-axis slices from the apex to the base will be assessed. By planimetry of all short-axis views, left ventricular end-systolic volume (in milliliters), left ventricular end-diastolic volume (in milliliters), and ejection fraction (in percent) will be determined.
Time Frame
6 months
Title
Changes from baseline in left ventricular volume at 6 months
Description
Changes in diastolic and systolic volume indices (assessed by magnetic resonance imaging at baseline and 9 months post-procedure)
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
chronic total occlusion with thrombolysis in myocardial infarction (TIMI) 0 flow (or distal capillary reflow) of a native coronary artery with an estimated reference vessel diameter of 2.5 to 4.0 mm
chronic total occlusion has more than 4 weeks duration
the target vessel has not previously been treated with percutaneous coronary intervention
the target vessel must be feasible for stent implantation
patient has stable or unstable angina pectoris or a positive functional study for ischemia
patient must be 18 years of age or older
female subjects of childbearing age must have a negative pregnancy test within 7 days before procedure
patient has been informed of the nature of the study and agrees to its
provisions ans has written informed consent as approved by the Ethics Committee
patient complies with all required post-procedure follow-up
Exclusion Criteria:
a documented left ventricular function < 30%
patient has a acute myocardial infarction (>3x normal creatine kinase (CK with presence of CK-MB) within 72 hours preceding the index procedure and CK has not returned to normal limits at the time of the procedure
patients with known hypersensitivity or contraindication to aspirin, heparin, clopidogrel, stainless steel or contrast media that cannot be adequately been pre-medicated
patient has a platelet count of < 100000 cells/mm3 or > 700000 cells/m3, a white blood cell count of < 3000 cells/mm3 or documented or suspected liver disease
patient has a history of bleeding diathesis or coagulopathy
patient has suffered a cerebrovascular accident or transient ischemic attack within the past 6 months
active peptic ulcer or upper gastrointestinal bleeding within the prior 6 months
patients has a co-morbidity (i.e. cancer or congestive heart failure) that may cause the patient to be non-compliant with the protocol, or is associated with limited life-expectancy (less than 2 years)
the target vessel contains intraluminal thrombus
the target vessel or lesson shows angiographic evidence of severe calcification
patient has contraindications to magnetic resonance imaging
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Heinz Joachim Buettner, MD
Organizational Affiliation
Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany
Official's Role
Principal Investigator
Facility Information:
Facility Name
Universitäts Herzzentrum Freiburg Bad Krozingen
City
Bad Krozingen
State/Province
Baden-Württemberg
ZIP/Postal Code
79189
Country
Germany
12. IPD Sharing Statement
Learn more about this trial
Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries
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