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Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease (POL-MIDES)

Primary Purpose

Heart Disease, Myocardial Ischaemia, Coronary Disease

Status
Completed
Phase
Phase 2
Locations
Poland
Study Type
Interventional
Intervention
Hybrid revascularization
Coronary Artery Bypass Grafting
Sponsored by
Silesian Centre for Heart Diseases
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Heart Disease focused on measuring Multivessel coronary artery disease, Hybrid revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Interventions, Drug eluting stents

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
  • Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Hybrid revascularization

Coronary Artery Bypass Grafting

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.

Full Information

First Posted
December 16, 2009
Last Updated
December 1, 2013
Sponsor
Silesian Centre for Heart Diseases
Collaborators
Ministry of Science and Higher Education, Poland
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1. Study Identification

Unique Protocol Identification Number
NCT01035567
Brief Title
Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease
Acronym
POL-MIDES
Official Title
Prospective Randomised Pilot Study Evaluating the Safety and Efficacy of Hybrid Revascularization in Multivessel Coronary Artery Disease
Study Type
Interventional

2. Study Status

Record Verification Date
December 2013
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Silesian Centre for Heart Diseases
Collaborators
Ministry of Science and Higher Education, Poland

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Disease, Myocardial Ischaemia, Coronary Disease, Coronary Artery Disease
Keywords
Multivessel coronary artery disease, Hybrid revascularization, Coronary Artery Bypass Grafting, Percutaneous Coronary Interventions, Drug eluting stents

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hybrid revascularization
Arm Type
Active Comparator
Arm Title
Coronary Artery Bypass Grafting
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Hybrid revascularization
Intervention Description
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
Intervention Type
Procedure
Intervention Name(s)
Coronary Artery Bypass Grafting
Intervention Description
Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments
Time Frame
1 year
Title
Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2
Time Frame
1 year
Title
Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups.
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Marian Zembala, PhD
Organizational Affiliation
Silesian Center for Heart Disease
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mariusz Gasior, PhD
Organizational Affiliation
Silesian Center for Heart Disease
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Cardiosurgery and Transplatology, Silesian Medical University, Silesian Center for Heart Disease
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
Third Department of Cardiology, Silesian Medical University, Silesian Center for Heart Disease
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
9769007
Citation
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.
Results Reference
background
PubMed Identifier
10504652
Citation
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.
Results Reference
background
PubMed Identifier
12142196
Citation
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.
Results Reference
background
PubMed Identifier
12400817
Citation
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.
Results Reference
background
PubMed Identifier
29680218
Citation
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.
Results Reference
derived
PubMed Identifier
25459040
Citation
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.
Results Reference
derived
PubMed Identifier
21594832
Citation
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.
Results Reference
derived

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Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease

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