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Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery (OCTOSTENT)

This study has been completed.
Sponsor:
Collaborators:
St. Antonius Hospital
Isala Klinieken
Information provided by:
UMC Utrecht
ClinicalTrials.gov Identifier:
NCT00975858
First received: September 11, 2009
Last updated: September 14, 2009
Last verified: September 2009
History of Changes
  Purpose

The randomized comparison of two strategies in coronary revascularization: bypass surgery without the use of a heart lung machine and coronary stenting procedure.

The comparison comprised the occurrence of cardiac adverse events after the procedure. In addition, costs, cognitive outcomes and angiography were assessed.


Condition Intervention
Coronary Artery Disease
 Procedure: Coronary Revascularization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Randomized Comparison of Long-term Clinical , Neurocognitive, Angiographical and Health-costs, After Stenting Versus Off-pump Coronary Bypass Surgery in Patients With Symptomatic Coronary Artery Disease

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Major Adverse Cardiac Events [ Time Frame: 7.5 years ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
  • Neurocognitive outcome [ Time Frame: 7.5 years ] [ Designated as safety issue: Yes ]
  • Cost effectiveness [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]
  • Angiographical patency of revascularization [ Time Frame: 7.5 years ] [ Designated as safety issue: No ]

Enrollment: 280
Study Start Date: January 1998
Study Completion Date: February 2001
Primary Completion Date: January 2001 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Percutaneous Coronary Intervention Procedure: Coronary Revascularization
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
Other Names:
  • Stenting
  • PCI
  • OPCAB
  • MICAB
Experimental: Off Pump Coronary Artery Bypass Surgery Procedure: Coronary Revascularization
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
Other Names:
  • Stenting
  • PCI
  • OPCAB
  • MICAB

Detailed Description:

Coronary artery bypass surgery with use of the heart lung machine (on-pump surgery), is associated with the risk of peri-operative complications such as death, stroke, myocardial infarction, neurocognitive decline, and extended hospitalization. Bypass surgery on the beating heart without the use of the heart lung machine (off-pump surgery) has been reintroduced in clinical practice in order to reduce these complications. The Octopus cardiac wall stabilizer, developed at the UMC Utrecht, facilitates the safe construction of the grafts during the off-pump procedure. The expected advantages of off-pump surgery e.g. less-invasiveness, complete arterial revascularization, faster recovery and lower costs were the basis for the Octostent trial. We hypothesized that the off-pump surgical technique might offer an alternative for angioplasty with bare-metal stent-implantation.

The current study was designed as a randomized controlled multicenter trial comparing two strategies.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with coronary artery disease referred for PCI in which both Off Pump Coronary Bypass surgery and PCI were deemed technically feasible

Exclusion Criteria:

  • a history of CABG or stenting
  • emergency or concomitant major surgery
  • Q-wave myocardial infarction in the last six weeks
  • inability to give informed consent
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00975858

Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
St. Antonius Hospital
Isala Klinieken
Investigators
Principal Investigator: Hendrik M Nathoe, MD PhD UMC Utrecht
  More Information

Publications:

Responsible Party: JJ Regiel, MD / HM Nathoe, MD,PhD, UMC Utrecht
ClinicalTrials.gov Identifier: NCT00975858     History of Changes
Other Study ID Numbers: WOM protocol 98/009
Study First Received: September 11, 2009
Last Updated: September 14, 2009
Health Authority: Netherlands: Medical Ethics Review Committee (METC)

Keywords provided by UMC Utrecht:
Symptomatic Coronary Artery Disease Patients

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 June 18, 2013