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

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Coronary Revascularization
Sponsored by
UMC Utrecht
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Coronary Artery Disease focused on measuring Symptomatic Coronary Artery Disease Patients

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UMC Utrecht

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Percutaneous Coronary Intervention

Off Pump Coronary Artery Bypass Surgery

Arm Description

Outcomes

Primary Outcome Measures

Major Adverse Cardiac Events

Secondary Outcome Measures

Quality of Life
Neurocognitive outcome
Cost effectiveness
Angiographical patency of revascularization

Full Information

First Posted
September 11, 2009
Last Updated
September 14, 2009
Sponsor
UMC Utrecht
Collaborators
St. Antonius Hospital, Isala
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1. Study Identification

Unique Protocol Identification Number
NCT00975858
Brief Title
Long-term Comparison of Stenting Versus Off-pump Coronary Bypass Surgery
Acronym
OCTOSTENT
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2009
Overall Recruitment Status
Completed
Study Start Date
January 1998 (undefined)
Primary Completion Date
January 2001 (Actual)
Study Completion Date
February 2001 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
UMC Utrecht
Collaborators
St. Antonius Hospital, Isala

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Artery Disease
Keywords
Symptomatic Coronary Artery Disease Patients

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
280 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Percutaneous Coronary Intervention
Arm Type
Active Comparator
Arm Title
Off Pump Coronary Artery Bypass Surgery
Arm Type
Experimental
Intervention Type
Procedure
Intervention Name(s)
Coronary Revascularization
Other Intervention Name(s)
Stenting, PCI, OPCAB, MICAB
Intervention Description
revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease
Primary Outcome Measure Information:
Title
Major Adverse Cardiac Events
Time Frame
7.5 years
Secondary Outcome Measure Information:
Title
Quality of Life
Time Frame
7.5 years
Title
Neurocognitive outcome
Time Frame
7.5 years
Title
Cost effectiveness
Time Frame
7.5 years
Title
Angiographical patency of revascularization
Time Frame
7.5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hendrik M Nathoe, MD PhD
Organizational Affiliation
UMC Utrecht
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMC Utrecht
City
Utrecht
Country
Netherlands

12. IPD Sharing Statement

Citations:
PubMed Identifier
14656913
Citation
Eefting F, Nathoe H, van Dijk D, Jansen E, Lahpor J, Stella P, Suyker W, Diephuis J, Suryapranata H, Ernst S, Borst C, Buskens E, Grobbee D, de Jaegere P. Randomized comparison between stenting and off-pump bypass surgery in patients referred for angioplasty. Circulation. 2003 Dec 9;108(23):2870-6. doi: 10.1161/01.CIR.0000100723.50363.2C. Epub 2003 Dec 1.
Results Reference
result

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

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