We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00975858
First Posted: September 14, 2009
Last Update Posted: September 15, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
St. Antonius Hospital
Isala
Information provided by:
UMC Utrecht
  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
Intervention Model: Parallel Assignment
Masking: None (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:


Further study details as provided by UMC Utrecht:

Primary Outcome Measures:
  • Major Adverse Cardiac Events [ Time Frame: 7.5 years ]

Secondary Outcome Measures:
  • Quality of Life [ Time Frame: 7.5 years ]
  • Neurocognitive outcome [ Time Frame: 7.5 years ]
  • Cost effectiveness [ Time Frame: 7.5 years ]
  • Angiographical patency of revascularization [ Time Frame: 7.5 years ]

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

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00975858


Locations
Netherlands
UMC Utrecht
Utrecht, Netherlands
Sponsors and Collaborators
UMC Utrecht
St. Antonius Hospital
Isala
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
First Submitted: September 11, 2009
First Posted: September 14, 2009
Last Update Posted: September 15, 2009
Last Verified: September 2009

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