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

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

Status
Enrolling by invitation
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06629701
Acronym
Vest II
Enrollment
150
Registered
2024-10-08
Start date
2024-01-01
Completion date
2027-12-31
Last updated
2026-04-09

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

Conditions

Heart Attack, Revascularization

Keywords

Heart attack, revascularization

Brief summary

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.

Detailed description

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.

Interventions

DEVICEExternal support for vein grafts

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

Sponsors

University Hospital Pilsen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Closing of bypass in time3 years after the operationPrimary measures will be closing of the bypass in time, if there will be any.

Secondary

MeasureTime frameDescription
Chest pain3 years after the operationChest pain
Shortness of breath at rest3 years after the operationShortness of breath at rest

Countries

Czechia

Contacts

PRINCIPAL_INVESTIGATORViktor Zlocha, MD

Head of Cardiac Surgery

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 10, 2026