Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries (REVASC)
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|ClinicalTrials.gov Identifier: NCT01924962|
Recruitment Status : Completed
First Posted : August 19, 2013
Last Update Posted : November 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Coronary Heart Disease||Device: revascularisation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||205 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Comparison of Recanalisation With Implantation of Cypher Sirolimus Eluting Coronary Stents and Medical Therapy|
|Actual Study Start Date :||May 28, 2008|
|Actual Primary Completion Date :||August 14, 2016|
|Actual Study Completion Date :||June 16, 2017|
No Intervention: medical therapy
patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.
Active Comparator: revascularisation
revascularisation and stent-implantation of chronic occluded coronary artery
revascularisation of chronic occluded coronary artery
Other Name: Cypher-stent
- Changes from baseline in regional left ventricular function at 9 months [ Time Frame: 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.
- Change from baseline in global left ventricular function at 6 months [ Time Frame: 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 [ Time Frame: 6 months ]Changes in diastolic and systolic volume indices (assessed by magnetic resonance imaging at baseline and 9 months post-procedure)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01924962
|Universitäts Herzzentrum Freiburg Bad Krozingen|
|Bad Krozingen, Baden-Württemberg, Germany, 79189|
|Principal Investigator:||Heinz Joachim Buettner, MD||Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany|