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Hybrid Revascularisation by Combined Coronary Artery Bypass Graft (CABG) and PCI in Multivessel Coronary Disease

NCT01443754 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2016-10-03

No results posted yet for this study

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 procedure(s). No new testing or procedures will be done.

Patients elected for hybrid revascularization will be asked their written consent to the use of their personal data.

Left internal mammary artery to the Left Anterior Descending Coronary Artery (LIMA-LAD)surgical revascularization will be performed first, followed by percutaneous revascularization of the other vessels in the frame of the same hospitalization.

After discharge patients will attend clinic visits at 30 days and 12 months, as per usual clinical practice, and will be contacted by phone at 6 months after procedure. Angiographic follow-up will be performed in symptomatic patients, as clinically indicated.

Conditions

  • Coronary Artery Disease (CAD)

Interventions

PROCEDURE

LIMA-LAD surgical revascularization

Off-pump coronary artery bypass (OPCAB) in which coronary revascularization is performed on the beating heart will be followed, the choice of the technical solutions being left at the discretion of the cardiac surgeon: * use of a left anterior small thoracotomy (LAST), LIMA harvesting using thoracoscopic methods and manual anastomosis of the LIMA-LAD using a stabilization device; * minimally invasive direct coronary bypass surgery (MIDCAB). The procedures can be performed alone or in combination with one another.

PROCEDURE

PCI

State of the art drug eluting stent (DES)-based percutaneous coronary intervention will be used by each participating site, according to current international guidelines. Zotarolimus, everolimus or sirolimus drug-eluting stents will be used in all sites.

Sponsors & Collaborators

  • Ettore Sansavini Health Science Foundation

    lead OTHER

Principal Investigators

  • Mauro Del Giglio, MD · GVM Care & Research

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01443754 on ClinicalTrials.gov