Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease
NCT ID: NCT01035567
Last Updated: 2013-12-03
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
PHASE2/PHASE3
200 participants
INTERVENTIONAL
2009-11-30
2013-10-31
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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Hybrid revascularization
Hybrid revascularization
First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery
Coronary Artery Bypass Grafting
Coronary Artery Bypass Grafting
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
Interventions
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Hybrid revascularization
First stage: implantation of the internal mammary artery into LAD in MIDCAB/TECAB procedure Second stage: PCI with drug eluting stents in other coronary arteries qualified for revascularization within 36 hours after surgery
Coronary Artery Bypass Grafting
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
Eligibility Criteria
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Inclusion Criteria
* Angiographically confirmed multivessel CAD with involved LAD and critical (\>70%)lesion in at least one (apart LAD) major epicardial vessel amenable to both PCI and CABG
* Indication for revascularization based upon symptoms of angina and/or objective evidence of myocardial ischaemia
* Patient is willing to comply with all follow-up visits
* Patient signed an Informed Consent
Exclusion Criteria
* Prior surgery with the opening of pericardium or pleura
* Prior stroke (within 6 months)or more than 6 months if there are substantial neurological defects
* Prior history of significant bleeding (within previous 6 months) that might be expected to occur during PCI/CABG related anticoagulation
* One or more chronic total occlusions in major coronary territories
* Left main stenosis (at least 50% diameter stenosis)
* Acute ST-elevation MI within 72 hours prior to enrollment requiring revascularization
* Planned simultaneous surgical procedure unrelated to coronary revascularization (e.g. valve repair/replacement, aneurysmectomy, carotid endarterectomy or carotid stenting)
* Contraindication to either CABG, MIDCAB or PCI/DES because of a coexisting clinical condition
* Significant leukopenia, neutropenia, thrombocytopenia, anemia, or known bleeding diathesis.
* Intolerance or contraindication to aspirin or both clopidogrel and ticlopidine
* Extra-cardiac illness that is expected to limit survival to less than 5 years e.g. oxygen-dependent chronic obstructive pulmonary disease, active hepatitis or significant hepatic failure, severe renal disease
* Suspected pregnancy. A pregnancy test will be administered prerandomization to all women of child-bearing age
* Concurrent enrollment in another clinical trial
* Patient inaccessible for follow-up visits required by protocol
18 Years
ALL
No
Sponsors
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Ministry of Science and Higher Education, Poland
OTHER_GOV
Silesian Centre for Heart Diseases
OTHER
Responsible Party
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Marian Zembala
MD, PhD, Head of the Cardiosurgery and Transplantology Department
Principal Investigators
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Marian Zembala, PhD
Role: PRINCIPAL_INVESTIGATOR
Silesian Center for Heart Disease
Mariusz Gasior, PhD
Role: STUDY_CHAIR
Silesian Center for Heart Disease
Locations
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Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, , Poland
Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, , Poland
Countries
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References
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Riess FC, Schofer J, Kremer P, Riess AG, Bergmann H, Moshar S, Mathey D, Bleese N. Beating heart operations including hybrid revascularization: initial experiences. Ann Thorac Surg. 1998 Sep;66(3):1076-81. doi: 10.1016/s0003-4975(98)00714-0.
Wittwer T, Cremer J, Klima U, Wahlers T, Haverich A. Myocardial "hybrid" revascularization: intermediate results of an alternative approach to multivessel coronary artery disease. J Thorac Cardiovasc Surg. 1999 Oct;118(4):766-7. doi: 10.1016/S0022-5223(99)70035-8. No abstract available.
Cisowski M, Morawski W, Drzewiecki J, Kruczak W, Toczek K, Bis J, Bochenek A. Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization. Eur J Cardiothorac Surg. 2002 Aug;22(2):261-5. doi: 10.1016/s1010-7940(02)00262-2.
Stahl KD, Boyd WD, Vassiliades TA, Karamanoukian HL. Hybrid robotic coronary artery surgery and angioplasty in multivessel coronary artery disease. Ann Thorac Surg. 2002 Oct;74(4):S1358-62. doi: 10.1016/s0003-4975(02)03889-4.
Tajstra M, Hrapkowicz T, Hawranek M, Filipiak K, Gierlotka M, Zembala M, Gasior M, Zembala MO; POL-MIDES Study Investigators. Hybrid Coronary Revascularization in Selected Patients With Multivessel Disease: 5-Year Clinical Outcomes of the Prospective Randomized Pilot Study. JACC Cardiovasc Interv. 2018 May 14;11(9):847-852. doi: 10.1016/j.jcin.2018.01.271. Epub 2018 Apr 18.
Gasior M, Zembala MO, Tajstra M, Filipiak K, Gierlotka M, Hrapkowicz T, Hawranek M, Polonski L, Zembala M; POL-MIDES (HYBRID) Study Investigators. Hybrid revascularization for multivessel coronary artery disease. JACC Cardiovasc Interv. 2014 Nov;7(11):1277-83. doi: 10.1016/j.jcin.2014.05.025. Epub 2014 Nov 17.
Zembala M, Tajstra M, Zembala M, Filipiak K, Knapik P, Hrapkowicz T, Gierlotka M, Hawranek M, Polonski L, Gasior M. Prospective randomised pilOt study evaLuating the safety and efficacy of hybrid revascularisation in MultI-vessel coronary artery DisEaSe (POLMIDES) - study design. Kardiol Pol. 2011;69(5):460-6.
Other Identifiers
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N R13 008406/2009
Identifier Type: -
Identifier Source: org_study_id