NCT06629701

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
20mo left

Started Jan 2024

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Jan 2024Dec 2027

Study Start

First participant enrolled

January 1, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 8, 2024

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

4 years

First QC Date

October 1, 2024

Last Update Submit

April 8, 2026

Conditions

Heart Attack, Revascularization

Keywords

Heart attack, revascularization

Outcome Measures

Primary Outcomes (1)

  • Closing of bypass in time

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

    3 years after the operation

Secondary Outcomes (2)

  • Chest pain

    3 years after the operation

  • Shortness of breath at rest

    3 years after the operation

Study Arms (2)

Group A

EXPERIMENTAL

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

Device: External support for vein grafts

Group B

NO INTERVENTION

Group B will be without sewn-in external supports.

Interventions

External support for vein graftsDEVICE

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

Group A

Eligibility Criteria

Age20 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Pilsen

Pilsen, Czech Republic, 30100, Czechia

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Viktor Zlocha, MD

    Head of Cardiac Surgery

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 1, 2024

First Posted

October 8, 2024

Study Start

January 1, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CZ(1)