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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
Sponsor:
Information provided by (Responsible Party):
Dr. Heinz Joachim Buettner, Heart Center Bad Krozingen

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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Device: revascularisation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 205 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Arm Intervention/treatment
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
Device: revascularisation
revascularisation of chronic occluded coronary artery
Other Name: Cypher-stent




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Locations
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Germany
Universitäts Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden-Württemberg, Germany, 79189
Sponsors and Collaborators
Heart Center Bad Krozingen
Investigators
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Principal Investigator: Heinz Joachim Buettner, MD Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany

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Responsible Party: Dr. Heinz Joachim Buettner, head of cath-lab department, Heart Center Bad Krozingen
ClinicalTrials.gov Identifier: NCT01924962     History of Changes
Other Study ID Numbers: BK 1-2011
First Posted: August 19, 2013    Key Record Dates
Last Update Posted: November 7, 2017
Last Verified: November 2017
Keywords provided by Dr. Heinz Joachim Buettner, Heart Center Bad Krozingen:
chronic occlusion of coronary artery
left ventricular function
revascularisation
Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases