A pilot study of stenting of autologous saphenous vein on early graft remodelling after coronary artery bypass surgery

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN77486578

Enrollment

Registered

2001-10-29

Start date

2005-03-01

Completion date

Unknown

Last updated

2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prevention of saphenous vein graft stenosis by the use of an external stent Surgery Other and unspecified disorders of circulatory system

Interventions

1. One group of patients will receive conventional bypass graft surgery with saphenous vein 2. In the second group the saphenous vein will be supported with a polyester made stent

Eligibility

Inclusion criteria

Inclusion criteria: Patients undergoing coronary artery bypass surgery

Exclusion criteria

Exclusion criteria: 1. Re-do surgery 2. First CABG with an associated procedure 3. Associated valve disease 4. Recent MI (<1 month) 5. Poor ejection fraction (<30%) 6. Diabetes 7. Previous history of inflammatory disease 8. Unwillingness to participate in follow-up

Design outcomes

Primary

Measure	Time frame
Study endpoints: Graft wall thickness and luminal size using intravascular ultrasound (IVUS) at time of operation and at follow-up. Wall and luminal volume will be computed from the 3-D reconstructions and compared to values obtained intraoperatively. Final wall and luminal volumes and the changes in these parameters will be compared in stented and unstented grafts. Angiography will be carried out as a necessary adjunct to intravascular ultrasound at follow-up. Clinical Outcomes: Adverse clinical events, including death, myocardial infarction, bleeding, infections, need for reoperation, recurrence of symptoms will be recorded.	—

Measure

Time frame

Study endpoints: Graft wall thickness and luminal size using intravascular ultrasound (IVUS) at time of operation and at follow-up. Wall and luminal volume will be computed from the 3-D reconstructions and compared to values obtained intraoperatively. Final wall and luminal volumes and the changes in these parameters will be compared in stented and unstented grafts. Angiography will be carried out as a necessary adjunct to intravascular ultrasound at follow-up. Clinical Outcomes: Adverse clinical events, including death, myocardial infarction, bleeding, infections, need for reoperation, recurrence of symptoms will be recorded.

—

Secondary

Measure	Time frame
Not provided at time of registration	—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026