Coronary Stenting and Coronary Bypass Grafting at the Same Time in a Specialty Built Operating Room

NCT00366015 | Completed

• 2 other identifiers: R-04-1589874
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This study will combine coronary stenting with minimally invasive robotic coronary bypass surgery, accomplished with the use of the da Vinci robot, to restore blood flow to occluded coronary arteries. Two previously approved and commonly performed procedures used to treat coronary artery disease(coronary stenting and robotic bypass surgery) are being combined into a hybrid surgery in a specialty built operating room. Patients with low risk coronary lesions will undergo cardiac hybrid revascularization using stenting and LIMA to LAD robotic bypass concomitantly. Patients' postoperative bleeding rates, angiographs and complication free rates will be recorded.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Disease; PCI; Drug eluting stents; Coronary Hybrid Revascularization; Robotic CABG

Outcome Measures

Primary Outcomes (1)

• Safety & efficacy of integrated myocardial revascularization performed in a single stage

  5 years post end of study

Secondary Outcomes (8)

• One-year postoperative stenosis rate (Stenosis may be evaluated by the angiographic documentation of blood flow).

  One year

• Success rate is defined as a reduction in stenosis to < 50%.

  One year

• Myocardial infarction,

  within 30 days of surgery

• Death,

  within 30 days of surgery and/or within primary hospitalization

• Repeat revascularization at any time after the robotic hybrid revascularization (Repeat revascularization are those involving a previously treated lesionfollowing the initial hybrid procedure)

  One year

Interventions

Robotic-assisted Coronary Surgical Revascularization PROCEDURE

Robotic assistance of coronary artery bypass grafting using the DaVinci surgical robotic console

PCI- Drug Eluting Stents PROCEDURE

Drug eluting stents performed by cardiologist within the same operating theatre following robotic assisted coronary artery bypass surgery

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with class A or B1 low risk coronary artery lesion as defined by TIMI

You may not qualify if:

• Contraindications to PCI which include:
• Occluded coronary vessels, PVD, Unable to achieve access, Fresh thrombus, Vessels \<1.5mm
• Contraindications to Robotic Surgery which include:
• Buried LAD, Unable to tolerate single lung ventilation, Inability to undergo beating heart surgery, Previous surgery of the left chest cavity, Lack of intrathoracic work space, Patients requiring emergency surgery,
• The following patients are also excluded:
• Patients with coagulation disorders; inability to tolerate GIIb/III inhibitors, Patients with ventricular arrhythmias, Patients with severe non-cardiac conditions with poor prognosis, Patients with a BMI \>40, Patients with an ejection fraction of \<30%, Patients with chronic renal insufficiency and creatinine \>200umol/L, Patients who are \>85 years of age, Patients participating in any other investigational device or study drug, Patients who have had previous thoracic surgery, Patients who have a pre-op intra-aortic balloon pump, Patients who are not able to follow the protocol requirements, Patients undergoing concomitant surgery; CABG + Valve surgery

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canada Foundation for Innovation: collaborator
• Ontario Innovative Trust: collaborator
• Ontario Research and Development Challenge Fund: collaborator

Study Sites (1)

The London Health Sciences Centre, University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (10)

• Merry AF, Raudkivi PJ, Middleton NG, McDougall JM, Nand P, Mills BP, Webber BJ, Frampton CM, White HD. Bivalirudin versus heparin and protamine in off-pump coronary artery bypass surgery. Ann Thorac Surg. 2004 Mar;77(3):925-31; discussion 931. doi: 10.1016/j.athoracsur.2003.09.061.

  PMID: 14992900 BACKGROUND

• Koster A, Spiess B, Chew DP, Krabatsch T, Tambeur L, DeAnda A, Hetzer R, Kuppe H, Smedira NG, Lincoff AM. Effectiveness of bivalirudin as a replacement for heparin during cardiopulmonary bypass in patients undergoing coronary artery bypass grafting. Am J Cardiol. 2004 Feb 1;93(3):356-9. doi: 10.1016/j.amjcard.2003.10.021.

  PMID: 14759391 BACKGROUND

• Vassiliades TA Jr, Douglas JS, Morris DC, Block PC, Ghazzal Z, Rab ST, Cates CU. Integrated coronary revascularization with drug-eluting stents: immediate and seven-month outcome. J Thorac Cardiovasc Surg. 2006 May;131(5):956-62. doi: 10.1016/j.jtcvs.2005.10.058. Epub 2006 Apr 27.

  PMID: 16678575 BACKGROUND

• Katz MR, Van Praet F, de Canniere D, Murphy D, Siwek L, Seshadri-Kreaden U, Friedrich G, Bonatti J. Integrated coronary revascularization: percutaneous coronary intervention plus robotic totally endoscopic coronary artery bypass. Circulation. 2006 Jul 4;114(1 Suppl):I473-6. doi: 10.1161/CIRCULATIONAHA.105.001537.

  PMID: 16820621 BACKGROUND

• Cisowski M, Morawski W, Drzewiecki J, Kruczak W, Toczek K, Bis J, Bochenek A. Integrated minimally invasive direct coronary artery bypass grafting and angioplasty for coronary artery revascularization. Eur J Cardiothorac Surg. 2002 Aug;22(2):261-5. doi: 10.1016/s1010-7940(02)00262-2.

  PMID: 12142196 BACKGROUND

• Zenati M, Cohen HA, Griffith BP. Alternative approach to multivessel coronary disease with integrated coronary revascularization. J Thorac Cardiovasc Surg. 1999 Mar;117(3):439-44; discussion 444-6. doi: 10.1016/s0022-5223(99)70322-3.

  PMID: 10047645 BACKGROUND

• Angelini GD, Wilde P, Salerno TA, Bosco G, Calafiore AM. Integrated left small thoracotomy and angioplasty for multivessel coronary artery revascularisation. Lancet. 1996 Mar 16;347(9003):757-8. doi: 10.1016/s0140-6736(96)90107-5. No abstract available.

  PMID: 8602013 BACKGROUND

• Bonatti J, Schachner T, Bonaros N, Laufer G, Kolbitsch C, Margreiter J, Jonetzko P, Pachinger O, Friedrich G. Robotic totally endoscopic coronary artery bypass and catheter based coronary intervention in one operative session. Ann Thorac Surg. 2005 Jun;79(6):2138-41. doi: 10.1016/j.athoracsur.2003.12.074.

  PMID: 15919329 BACKGROUND

• Bonatti J, Schachner T, Bonaros N, Jonetzko P, Ohlinger A, Lockinger A, Stalzer B, Eschertzhuber S, Friedrich G. Treatment of double vessel coronary artery disease by totally endoscopic bypass surgery and drug-eluting stent placement in one simultaneous hybrid session. Heart Surg Forum. 2005;8(4):E284-6. doi: 10.1532/HSF98.20051136.

  PMID: 16112943 BACKGROUND

• Dogan S, Aybek T, Andressen E, Byhahn C, Mierdl S, Westphal K, Matheis G, Moritz A, Wimmer-Greinecker G. Totally endoscopic coronary artery bypass grafting on cardiopulmonary bypass with robotically enhanced telemanipulation: report of forty-five cases. J Thorac Cardiovasc Surg. 2002 Jun;123(6):1125-31. doi: 10.1067/mtc.2002.121305.

  PMID: 12063459 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Bob Kiaii, MD, FRCSC

  Department of Cardiac Surgery, University of Western Ontario and the London Health Sciences Centre, University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2006
• First Posted: August 18, 2006
• Study Start: July 29, 2003
• Primary Completion: December 31, 2010
• Study Completion: December 31, 2010
• Last Updated: August 28, 2017

Record last verified: 2017-08

Locations

CA (1)