Coronary Hybrid Revascularisation Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Aarhus University Hospital Skejby
Sponsor:
Information provided by (Responsible Party):
Jens Flensted Lassen, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier:
NCT01496664
First received: December 19, 2011
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention Phase
Significant Coronary Artery Disease
Procedure: Combined CABG and PCI
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Coronary Hybrid Revascularisation Study Registry on Treatment of Significant Coronary Artery Disease by Combined Bypass Operation (CABG) and Catheter Based Treatment (PCI)

Resource links provided by NLM:


Further study details as provided by Aarhus University Hospital Skejby:

Primary Outcome Measures:
  • Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE [ Time Frame: After 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Combined endpoint of death, stroke, MI and new revascularisation. [ Time Frame: After 1 month and after 1, 3 and 5 years ] [ Designated as safety issue: Yes ]
  • Individual endpoints of death, stroke, MI and new revascularisation. [ Time Frame: After 1 month and after 1, 3 and 5 years ] [ Designated as safety issue: Yes ]
  • Death [ Time Frame: After 10 years ] [ Designated as safety issue: Yes ]
  • Procedure related biomarker release [ Designated as safety issue: Yes ]
  • Reoperation for bleeding [ Designated as safety issue: Yes ]
  • Operation for suspected sternal infection [ Designated as safety issue: Yes ]
  • CT verified pulmonary embolism [ Designated as safety issue: Yes ]
  • CCS angina class [ Designated as safety issue: Yes ]
  • NYHA function class [ Designated as safety issue: Yes ]
  • Duration of hospitalisation related to the index treatment [ Designated as safety issue: Yes ]
  • Duration of admission for the index treatment [ Designated as safety issue: Yes ]
  • Angiographic endpoints [ Designated as safety issue: Yes ]
    Presence of significant narrowing or occlusion of mammary or vein graft, or lesions treated with stent or balloon.


Estimated Enrollment: 2000
Study Start Date: September 2010
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Result of combined CABG and PCI treatment
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
Coronary artery bypass grafting Percutaneous coronary intervention

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01496664

Contacts
Contact: Jens F Lassen, MD +45 78450000 ext 52031 jens.lassen@ki.au.dk
Contact: Per H Nielsen, MD perhni@rm.dk

Locations
Denmark
Aarhus University Hospital, Skejby Recruiting
Aarhus N, Denmark, 8200
Contact: Per H Nielsen, MD    +45 89495566 ext 5402    perhni@rm.dk   
Principal Investigator: Jens F Lassen, MD         
Sponsors and Collaborators
Aarhus University Hospital Skejby
  More Information

Additional Information:
No publications provided

Responsible Party: Jens Flensted Lassen, MD, DMSc, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT01496664     History of Changes
Other Study ID Numbers: M-20100152
Study First Received: December 19, 2011
Last Updated: June 24, 2014
Health Authority: Denmark: National Board of Health

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014