Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborator:
Ministry of Science and Higher Education, Poland
Information provided by (Responsible Party):
Marian Zembala, Silesian Centre for Heart Diseases
ClinicalTrials.gov Identifier:
NCT01035567
First received: December 16, 2009
Last updated: December 1, 2013
Last verified: December 2013

December 16, 2009
December 1, 2013
November 2009
May 2013   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01035567 on ClinicalTrials.gov Archive Site
  • Postprocedure and follow up angiographic measurements as patency of grafts and restenosis in revascularized segments [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Assessment of quality of life of alive study participants according to SF-36 Health Survey version 2 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Cost-effectiveness defined as a cost of revascularization procedure and costs of hospitalizations in both groups. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study of Hybrid Revascularization in Multivessel Coronary Artery Disease
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.

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Heart Disease
  • Myocardial Ischaemia
  • Coronary Disease
  • Coronary Artery Disease
  • Procedure: 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
  • Procedure: Coronary Artery Bypass Grafting
    Coronary artery bypass grafting with sternotomy on or off the pump at discretion of the operator.
  • Active Comparator: Hybrid revascularization
    Intervention: Procedure: Hybrid revascularization
  • Active Comparator: Coronary Artery Bypass Grafting
    Intervention: Procedure: Coronary Artery Bypass Grafting

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
200
October 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Poland
 
NCT01035567
N R13 008406/2009
Yes
Marian Zembala, Silesian Centre for Heart Diseases
Silesian Centre for Heart Diseases
Ministry of Science and Higher Education, Poland
Principal Investigator: Marian Zembala, PhD Silesian Center for Heart Disease
Study Chair: Mariusz Gasior, PhD Silesian Center for Heart Disease
Silesian Centre for Heart Diseases
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP