DESolve® X-Pand Global Post Market Registry

Elixir Medical

Status: Terminated

Conditions: Coronary Artery Stenosis

Treatments: Device: PTCA - Desolve Scaffold

Study type: Observational

Funder types: NETWORK; Industry

Identifiers

NCT02453035

ELX-CL-1503

Details and patient eligibility

About

The X-Pand Registry is intended to facilitate analysis of acute & long-term safety as well as treatment outcomes with DESolve in patients with CAD.

Full description

The Xpand Registry is a single-arm, multi-center, clinical Follow up study of patients with significant coronary stenosis who are treated with a commercially available DESolve Scaffold.

The Registry is an observational study. The patients should be treated according to the current DESolve IFU, professional societies guidelines & internal hospital guidelines.

Enrollment: 154 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Minimal age 18 years
2. Patient is willing/able to cooperate with study procedures and required follow up visits. Patient or legal representative has been informed & agrees by signing EC approved written consent. Consent can occur before implantation of the DESolve scaffold (planned procedure) or within 30 days post implantation procedure for retrospective enrollment (unplanned procedure).
3. Planned or unplanned DESolve scaffold implantation

Exclusion criteria

None

Trial design

154 participants in 1 patient group

PTCA - Desolve Scaffold

Description:

Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold

Treatment:

Device: PTCA - Desolve Scaffold