- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01035567
Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease (POL-MIDES)
December 1, 2013 updated by: Marian Zembala, Silesian Centre for Heart Diseases
Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease
The purpose of the study is to assess the safety and efficacy of hybrid revascularization in comparison with coronary artery bypass grafting among patients with multivessel coronary artery disease.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
200
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Zabrze, Poland, 41-800
- Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
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Zabrze, Poland, 41-800
- Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age 18 or more
- 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:
- Severe congestive heart failure (class III or IV according to NYHA, or pulmonary edema, cardiogenic shock) at the time of enrollment
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Hybrid revascularization
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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
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ACTIVE_COMPARATOR: Coronary Artery Bypass Grafting
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Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Possibility defined by means of (1) a % of pts with complete hybrid procedure according to study protocol, and (2) a % of conversion to standard CABG. Safety defined as a occurrence of MACE such as death, MI, stroke, TVR, or major bleeding.
Time Frame: 1 year
|
1 year
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
Time Frame: 1 year
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1 year
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Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
Time Frame: 1 year
|
1 year
|
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.
Time Frame: 1 year
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1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Marian Zembala, PhD, Silesian Center for Heart Disease
- Study Chair: Mariusz Gasior, PhD, Silesian Center for Heart Disease
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2009
Primary Completion (ACTUAL)
May 1, 2013
Study Completion (ACTUAL)
October 1, 2013
Study Registration Dates
First Submitted
December 16, 2009
First Submitted That Met QC Criteria
December 17, 2009
First Posted (ESTIMATE)
December 18, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 3, 2013
Last Update Submitted That Met QC Criteria
December 1, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- N R13 008406/2009
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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