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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

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

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

Time Frame

9 months

Secondary Outcome Measure Information:

Title

Change from baseline in global left ventricular function at 6 months

Description

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

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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