Skip to main content
OpenTrials
Completed

NCT Number: NCT00975858

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UMC Utrecht

Utrecht, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coronary revascularization

Procedure

revascularization of coronary arteries in case of symptomatic obstructive coronary artery disease

Other names: Stenting, PCI, OPCAB, MICAB

Primary outcomes

  1. Major Adverse Cardiac Events

    Time frame: 7.5 years

Secondary outcomes

  1. Quality of Life

    Time frame: 7.5 years

  2. Neurocognitive outcome

    Time frame: 7.5 years

  3. Cost effectiveness

    Time frame: 7.5 years

  4. Angiographical patency of revascularization

    Time frame: 7.5 years

Sponsors and collaborators

Lead sponsor

UMC Utrecht

Other

Collaborators

  • Isala
  • St. Antonius Hospital

Registry information

Official study 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

Acronym: OCTOSTENT

Important dates

Study start
1998
Primary completion
2001
Study completion
2001
First posted
Sep 14, 2009
Registry last updated
Sep 15, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.