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External Vein Support Device

Single Vessel Treatment for Coronary Artery Disease (eMESH 1 Trial)

Phase 1 & 2
Waitlist Available
Led By John Puskas, MD
Research Sponsored by Kips Bay Medical, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Summary

Multi-center, dual cohort (randomized and single vessel) study designed to demonstrate feasibility, initial safety and performance of the Kips Bay Medical, Inc. eSVS® Mesh as an external vein support device for use over saphenous vein grafts during coronary artery bypass surgery. In the Randomized Cohort, each study subject will receive a SVG without Mesh (control) and a SVG with the eSVS Mesh (treatment). In the Single Vessel Cohort, each study subject will receive one SVG with the eSVS Mesh.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
MACE
Technical success implanting eSVS Mesh
Secondary study objectives
MACCE and mediastinitis
Plaque burden
SVG patency determined by angiography

Trial Design

3Treatment groups
Active Control
Placebo Group
Group I: Single Vessel TreatmentActive Control1 Intervention
Each subject with receive one SVG with eSVS Mesh either to the right or left coronary system.
Group II: eSVS Mesh treated saphenous vein graftActive Control1 Intervention
Each subject will be randomized to an eSVS Mesh treated SVG to the right or left coronary system.
Group III: Control saphenous vein graftPlacebo Group1 Intervention
Each subject will be randomized to an untreated (no eSVS Mesh) SVG to the right or left coronary system.

Find a Location

Who is running the clinical trial?

Kips Bay Medical, Inc.Lead Sponsor
3 Previous Clinical Trials
140 Total Patients Enrolled
3 Trials studying Coronary Artery Disease
140 Patients Enrolled for Coronary Artery Disease
John Puskas, MDPrincipal InvestigatorEmory University
4 Previous Clinical Trials
2,401 Total Patients Enrolled
2 Trials studying Coronary Artery Disease
424 Patients Enrolled for Coronary Artery Disease
Lars Englberger, MDPrincipal InvestigatorUniversity of Bern
1 Previous Clinical Trials
54 Total Patients Enrolled
~9 spots leftby Sep 2025
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