DESolve® X-Pand Global Post Market Registry

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Total Enrollment

154 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-13

Study Completion Date

2017-04-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Coronary Artery Stenosis

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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PTCA - Desolve Scaffold

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

PTCA - Desolve Scaffold

Intervention Type DEVICE

Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold

Interventions

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PTCA - Desolve Scaffold

Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold

Intervention Type DEVICE

Other Intervention Names

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PTA. PCI

Eligibility Criteria

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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