Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease
POL-MIDES
Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease
Sponsor study identifier
interventional
200
1 country
2
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
May 2013
Actual (reported)Study Completion
October 2013
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2013
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
December 16, 2009
Actual (reported)December 18, 2009
Actual (reported)May 2013
Actual (reported)October 2013
Actual (reported)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.
1 year
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
1 year
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
1 year
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 with sternotomy on or off the pump at discretion of the operator.
Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, 41-800, Poland
Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
Zabrze, 41-800, Poland
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.
Marian Zembala, PhD
Silesian Center for Heart Disease
Mariusz Gasior, PhD
Silesian Center for Heart Disease
200 participants (actual enrollment reported by the registry).
First Submitted
December 16, 2009
First Posted
December 18, 2009
Study Start
November 2009
Date type not reportedThis date has not been verified as actual or estimated.
China Made Sirolimus Eluting Stent for Intermediate Lesion
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.
1 year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
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.
Primary Completion
May 2013
Actual (reported)Study Completion
October 2013
Actual (reported)Last Updated
December 3, 2013
Record last verified: 2013-12
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