Trials / Completed
CompletedNCT02332330
CD0104 VEST II Post Marketing Surveillance Study
A Post-market Prospective Study of the VGS VEST (Venous External Support), Supporting Saphenous Vein Grafts for Coronary Bypass Graft Surgery in Patients With Severe Coronary Heart Disease
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Vascular Graft Solutions Ltd. · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
Summary
This study is designed to collect post market data on use of the VEST, particularly on saphenous vein grafts to the right territory of the heart.
Detailed description
The primary objective is to test the early-mid term patency rate of VEST supported Right Coronary Artery (RCA) bypass grafts. The research participants will undergo CABG preparations and CABG procedure routinely as is the standard of care. During the procedure the VEST will be implanted on the vein graft to the Right Coronary Artery according to the IFU. Perioperative care is according to standard of care. Upon discharge patient will be prescribed statins and aspirin for 6 months. Patient will attend a routine clinic visit 4-6 weeks post operatively. The last study visit will occur 3-6 months post operatively. Patients will undergo a noninvasive coronary CT angiography.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | VEST |
Timeline
- Start date
- 2015-01-01
- Primary completion
- 2016-01-01
- Completion
- 2016-04-01
- First posted
- 2015-01-06
- Last updated
- 2016-04-28
Locations
2 sites across 2 countries: Germany, United Kingdom
Source: ClinicalTrials.gov record NCT02332330. Inclusion in this directory is not an endorsement.