Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries (REVASC)

University Heart Center Freiburg - Bad Krozingen

Status

Completed

Conditions

Coronary Heart Disease

Treatments

Device: revascularisation

Study type

Interventional

Funder types

Other

Identifiers

NCT01924962

BK 1-2011

Details and patient eligibility

About

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.

Full 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.

Enrollment

205 patients

Sex

All

Ages

18+ years old

Volunteers

No 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