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Enrolling by Invitation

NCT Number: NCT06629701

A Prospective Randomized Trial of External Vein Graft Support in Surgical Myocardial Revascularization

The aim of the thesis is to compare a group of patients using vein grafts with and without external support, specifically their patency. This is a prospective study with a follow-up plan of 150 patients, in whom the functionality of the grafts will be monitored at time intervals.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

About this study

One of the most frequently used strategies to restore blood flow in affected coronary arteries in atherosclerotic disease is coronary bypass, or bridging of a narrowed or closed artery and revascularization of the ischemic area of the heart. For coronary artery bypass grafting (CABG), the great saphenous vein (VSM) remains the most commonly used graft, although the longevity of the vein graft is an important limiting factor in monitoring long-term results of CABG. Long-term follow-up found that 25% of vein grafts close within 1 year of surgery, and up to 75% of vein grafts close 10 years after surgery.

External support minimizes pathophysiological processes in the graft. For example, intimal hyperplasia, kinking, graft dilatation or graft suppression and generally improving the hemodynamic flow through the graft should also reduce the formation of thrombus. In this study we follow up the patency and function of vein grafts over a period of 4 years, and compare the resulting data with already available data from other researches.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • elective cardiosurgical revascularization using VSM vein graft, i.e. patients with MVD findings.

Exclusion criteria

  • thromboembolic event in the past, long-term warfarinization, mechanical valves, infection during the procedure, urgent procedure, allergy to contrast material, pregnancy, elevated creatinine. A relative contraindication for exclusion from the study is: VSM varicosity, VSM damage during sampling.The age, gender or weight of the patient has no influence on the indication.

Treatment and study plan

External support for vein grafts

Device

Group A will consist of a group of patients who will be sutured with external support for vein grafts.

Primary outcomes

  1. Closing of bypass in time

    Time frame: 3 years after the operation

    Primary measures will be closing of the bypass in time, if there will be any.

Secondary outcomes

  1. Chest pain

    Time frame: 3 years after the operation

    Chest pain

  2. Shortness of breath at rest

    Time frame: 3 years after the operation

    Shortness of breath at rest

Sponsors and collaborators

Lead sponsor

University Hospital Pilsen

Other

Registry information

Acronym: Vest II

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Oct 8, 2024
Registry last updated
Apr 9, 2026

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.

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