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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Combined CABG and PCI | Coronary 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.