Clinical Trials Logo
  1. Home
  2. Other
  3. NCT01496664
  4. Details
NCT01496664 Clinical Trial

Coronary Hybrid Revascularisation Study

Significant Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01496664
Other study ID # M-20100152
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
Start date September 2010
Est. completion date December 2022

Study information
Verified date February 2022
Source Aarhus University Hospital Skejby
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 2000
Est. completion date December 2022
Est. primary completion date September 2015
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Stable, unstable angina pectoris and ACS. - Significant stenosis of LAD, segment 1 or 2 and of other coronary arteries. - The patient can be treated with a mammary graft to LAD and by balloon or stent of other lesions. - Signed informed consent must be available. Exclusion Criteria: - Earlier cardiac surgery - Treatment with coronary stent within one year. - ST-elevation infarction within 24 hours. - Coronary artery lesions located to LAD, segment 1 or 2, which cannot be treated by coronary bypass operation. - Stenosis of diagonal branches, CX artery and the right coronary artery, which cannot be treated by PCI. - Expected survival <1 year following successful treatment. - Allergy to aspirin, clopidogrel, ticlopidine and/or prasugrel. - Allergy to sirolimus, everolimus, zotarolimus og biolimus For the patients treated with coronary hybrid intervention in the same seance further exclusion criteria: Known disorder of the bloods ability to coagulate (such as renal failure (dialysis or renal creatinine clearance < 50ml/min), congenital coagulopathy, needs for anticoagulant treatment before surgery) Previous gastrointestinal bleeding or previous cerebral

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• Combined CABG and PCI
Coronary artery bypass grafting Percutaneous coronary intervention

Locations
Country Name City State
Denmark Aarhus University Hospital, Skejby Aarhus N

Sponsors (1)
Lead Sponsor Collaborator
Aarhus University Hospital Skejby

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE After 1 year
Secondary Combined endpoint of death, stroke, MI and new revascularisation. After 1 month and after 1, 3 and 5 years
Secondary Individual endpoints of death, stroke, MI and new revascularisation. After 1 month and after 1, 3 and 5 years
Secondary Death Baseline, 1 month, 1, 2, 3, 4 and 10 years
Secondary Procedure related biomarker release Baseline, 1, 3 and 5 year
Secondary Reoperation for bleeding Baseline, 1, 3 and 5 year
Secondary Operation for suspected sternal infection Baseline, 1, 3 and 5 year
Secondary CT verified pulmonary embolism Baseline, 1, 3 and 5 year
Secondary CCS angina class 1, 3 and 5 year
Secondary NYHA function class 1, 3 and 5 year
Secondary Duration of hospitalisation related to the index treatment Baseline
Secondary Duration of admission for the index treatment Baseline
Secondary Angiographic endpoints Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon. 1 year

External Links