NCT01860274

Brief Summary

The study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone. To test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. A control angiography will be performed one year after the operation.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P25-P50 for not_applicable coronary-artery-disease

Timeline
Completed

Started Sep 2015

Typical duration for not_applicable coronary-artery-disease

Geographic Reach
1 country

2 active sites

Status
completed

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

First Submitted

Initial submission to the registry

May 20, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 22, 2013

Completed
2.3 years until next milestone

Study Start

First participant enrolled

September 6, 2015

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 28, 2020

Completed
Last Updated

March 12, 2021

Status Verified

March 1, 2021

Enrollment Period

4.3 years

First QC Date

May 20, 2013

Last Update Submit

March 10, 2021

Conditions

Coronary Artery Disease

Keywords

MeshGraftPatency

Outcome Measures

Primary Outcomes (1)

  • Patency

    Patency of graft at CT Scan

    6 to 12 months

Secondary Outcomes (2)

  • Major Adverse Cardiac and Cerebrovascular Events (MACCE)

    60 months

  • Vein graft lumen uniformity

    6 to 12 months

Study Arms (1)

External Mesh

EXPERIMENTAL
Device: External Mesh for vein grafts

Interventions

External Mesh for vein graftsDEVICE
External Mesh

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical Indication for elective Coronary Artery Bypass Grafting with at least one vein graft
  • Coronary artery with critical stenosis (over 70%)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

European Hospital

Rome, 00149, Italy

Location

Mauriziano Hospital

Turin, Italy

Location

Related Publications (1)

  • Weltert LP, Audisio K, Bellisaro A, Bardi G, Flocco R, De Paulis R, Centofanti P. External stenting of vein grafts in coronary artery bypass grating: interim results from a two centers prospective study. J Cardiothorac Surg. 2021 Apr 12;16(1):74. doi: 10.1186/s13019-021-01406-0.

    PMID: 33845865DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Luca Weltert, MD

    European Hospital - Rome

    PRINCIPAL INVESTIGATOR

  • Ruggero De Paulis, MD

    European Hospital - Rome

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 20, 2013

First Posted

May 22, 2013

Study Start

September 6, 2015

Primary Completion

December 31, 2019

Study Completion

June 28, 2020

Last Updated

March 12, 2021

Record last verified: 2021-03

Locations

IT(2)