Recovery of Left Ventricular Function in Chronic Total Occluded Coronary Arteries
NCT ID: NCT01924962
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
205 participants
INTERVENTIONAL
2008-05-28
2017-06-16
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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medical therapy
patients are treated with medical therapy only, intervention (stent) of other than (chronic occluded) target-vessel is allowed.
No interventions assigned to this group
revascularisation
revascularisation and stent-implantation of chronic occluded coronary artery
revascularisation
revascularisation of chronic occluded coronary artery
Interventions
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revascularisation
revascularisation of chronic occluded coronary artery
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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University Heart Center Freiburg - Bad Krozingen
OTHER
Responsible Party
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Dr. Heinz Joachim Buettner
head of cath-lab department
Principal Investigators
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Heinz Joachim Buettner, MD
Role: PRINCIPAL_INVESTIGATOR
Universitaets-Herzzentrum Freiburg-Bad Krozingen, Clinics for Cardiology and Angiology II, D-79189 Bad Krozingen, Germany
Locations
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Universitäts Herzzentrum Freiburg Bad Krozingen
Bad Krozingen, Baden-Wurttemberg, Germany
Countries
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Other Identifiers
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BK 1-2011
Identifier Type: -
Identifier Source: org_study_id