Clinical Trials Directory

Trials / Completed

CompletedNCT01496664

Coronary Hybrid Revascularisation Study

Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
2,000 (estimated)
Sponsor
Aarhus University Hospital Skejby · Academic / Other
Sex
All
Age
Healthy volunteers
Not accepted

Summary

The purpose of the registry is to assess results of combined operative and catheter based (hybrid procedure) treatment of patients with significant coronary artery disease using essential clinical and angiographic parameters. Based on existing literature we expect the results of coronary artery bypass grafting of the anterior descendent coronary artery (LAD), segment 1 and 2, using the so-called mammary artery graft, to be superior to stent treatment of the same artery. At the same time a catheter based intervention using balloon, bare metal stents (BMS) or drug eluting stents (DES) seems to be a better treatment that a saphenous vein graft for other coronary arteries than the LAD. I.e. the right coronary artery (RCA) and the left circumflex coronary artery (CX). Therefore, we expect a combination of the mentioned surgical and catheter based techniques to be a better treatment than bypass operation or catheter based intervention alone.

Detailed description

A total of 150 consecutive patients will be included in the study. The patients will have a coronary artery narrowing located to the LAD, which can be treated with a mammary graft, and a stenosis located to other coronary arteries (RCA and CX), which can be treated by balloon or stent. The patients included in the study will be recruited from patients who are referred to the Department of Cardiology/Department of Thoracic Surgery, Aarhus University Hospital, Skejby for treatment of significant coronary artery disease. We will not announce for patients, and the patients will not receive a honorarium for participation. The first 100 patients will be treated i two seances; operation and stent treatment with few days interval. The last 50 patients will be treated in a hybrid operation room with operation and stent treatment in the same seance.

Conditions

Interventions

TypeNameDescription
PROCEDURECombined CABG and PCICoronary artery bypass grafting Percutaneous coronary intervention

Timeline

Start date
2010-09-01
Primary completion
2015-09-01
Completion
2022-12-01
First posted
2011-12-21
Last updated
2026-01-02

Locations

1 site across 1 country: Denmark

Source: ClinicalTrials.gov record NCT01496664. Inclusion in this directory is not an endorsement.