Status:
TERMINATED
Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease
Lead Sponsor:
Ettore Sansavini Health Science Foundation
Conditions:
Coronary Artery Disease (CAD)
Eligibility:
All Genders
70+ years
Brief Summary
The present study is designed as a prospective, single centre, open label, observational trial. The study will collect information about the medical care patients receive during their planned procedu...
Detailed Description
Hybrid coronary revascularization integrates the positive features of both Percutaneous Coronary Intervention (PCI) and Coronary Artery Bypass Graft (CABG), combining the durability of Left Anterior D...
Eligibility Criteria
Inclusion
- Patients with multi-vessel coronary artery disease (CAD) amenable to hybrid revascularization and fulfilling the following criteria:
- ≥70% left-anterior descendent (LAD) obstruction suitable for surgical revascularization using the left internal mammary artery (LIMA);
- patients amenable to a off-pump beating heart revascularization procedure;
- non-LAD coronary lesions suitable for percutaneous coronary artery intervention (PCI), as adjudicated by one interventional cardiologist and one cardiac surgeon;
- ≥ 70 years of age
- Written informed consent for the use of personal data
Exclusion
- patients hemodynamically unstable;
- acute or recent (\< 1 month) myocardial infarction;
- severe heart failure (NYHA Class IV);
- creatinine \> 2.2 mg/dl;
- allergy to radiographic contrast;
- contraindication to double antiaggregation therapy (DAT) for at least 12 months;
- previous cardiac surgery of any type;
- previous thoracic surgery involving left pleural space;
- previous coronary stenting: within one month for BMS, within 6 months for DES;
- disabling stroke within previous 6 months;
- need for concomitant cardiac surgery during index hospitalization;
Key Trial Info
Start Date :
September 1 2011
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01443754
Start Date
September 1 2011
End Date
April 1 2016
Last Update
October 3 2016
Active Locations (1)
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1
Maria Cecilia Hospital
Cotignola, Ravenna, Italy, 48010