Coronary Hybrid Revascularisation Study

NCT01496664 | Completed DMC

• 1 other identifier: M-20100152
• Study Type: interventional
• Target: 2,000
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Significant Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE

  After 1 year

Secondary Outcomes (12)

• Combined endpoint of death, stroke, MI and new revascularisation.

  After 1 month and after 1, 3 and 5 years

• Individual endpoints of death, stroke, MI and new revascularisation.

  After 1 month and after 1, 3 and 5 years

• Death

  Baseline, 1 month, 1, 2, 3, 4 and 10 years

• Procedure related biomarker release

  Baseline, 1, 3 and 5 year

• Reoperation for bleeding

  Baseline, 1, 3 and 5 year

Study Arms (1)

Result of combined CABG and PCI treatment

EXPERIMENTAL

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.

Procedure: Combined CABG and PCI

Interventions

Combined CABG and PCI PROCEDURE

Coronary artery bypass grafting Percutaneous coronary intervention

Result of combined CABG and PCI treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Aarhus University Hospital Skejby: lead

Study Sites (1)

Aarhus University Hospital, Skejby

Aarhus N, 8200, Denmark

Location

Related Publications (3)

• Rimestad JM, Christiansen EH, Modrau IS. One-year cost-effectiveness and safety of simultaneous hybrid coronary revascularization versus conventional coronary artery bypass grafting. Interact Cardiovasc Thorac Surg. 2019 Aug 1;29(2):217-223. doi: 10.1093/icvts/ivz083. Epub 2019 Mar 21.

  PMID: 30903175 DERIVED

• Modrau IS, Holm NR, Maeng M, Botker HE, Christiansen EH, Kristensen SD, Lassen JF, Thuesen L, Nielsen PH; Hybrid Coronary Revascularization Study Group. One-year clinical and angiographic results of hybrid coronary revascularization. J Thorac Cardiovasc Surg. 2015 Nov;150(5):1181-6. doi: 10.1016/j.jtcvs.2015.08.072. Epub 2015 Aug 28.

  PMID: 26432721 DERIVED

• Modrau IS, Nielsen PH, Botker HE, Christiansen EH, Krusell LR, Kaltoft AK, Maeng M, Terkelsen CJ, Kristensen SD, Lassen JF, Thuesen L. Feasibility and early safety of hybrid coronary revascularisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention. EuroIntervention. 2015 Feb;10(10):e1-6. doi: 10.4244/EIJV10I10A195.

  PMID: 24103704 DERIVED

Related Links

• Feasibility and early safety of hybrid coronary revasculatisation combining off-pump coronary surgery through J-hemisternotomy with percutaneous coronary intervention
• One year clinical and angiographic results of hybrid coronary revascularisation
• Related Info

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, phd

Study Record Dates

• First Submitted: December 19, 2011
• First Posted: December 21, 2011
• Study Start: September 1, 2010
• Primary Completion: September 1, 2015
• Study Completion: December 1, 2022
• Last Updated: January 2, 2026

Record last verified: 2025-12

Locations

DK (1)