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

December 19, 2011
June 24, 2014
September 2010
October 2018   (final data collection date for primary outcome measure)
Combined endpoint of death, stroke, MI and new revascularisation (PCI or CABG) MACCE [ Time Frame: After 1 year ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01496664 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
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)

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.

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.

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Significant Coronary Artery Disease
Procedure: Combined CABG and PCI
Coronary artery bypass grafting Percutaneous coronary intervention
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.
Intervention: Procedure: Combined CABG and PCI
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
2000
October 2019
October 2018   (final data collection date for primary outcome measure)

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

Both
Not Provided
No
Contact: Jens F Lassen, MD +45 78450000 ext 52031 jens.lassen@ki.au.dk
Contact: Per H Nielsen, MD perhni@rm.dk
Denmark
 
NCT01496664
M-20100152
Yes
Jens Flensted Lassen, Aarhus University Hospital Skejby
Aarhus University Hospital Skejby
Not Provided
Not Provided
Aarhus University Hospital Skejby
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP