DESolve® X-Pand Global Post Market Registry

Terminated

• Conditions: Coronary Artery Stenosis
• Interventions: Device: PTCA - Desolve Scaffold

• Registration Number: NCT02453035
• Lead Sponsor: Elixir Medical Corporation

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2015-05-13
• Study First Submitted: 2015-05-13
• Study First Submitted QC: 2015-05-20
• Study First Posted: 2015-05-25
• Primary Completion: 2017-03-31
• Study Completion: 2017-04-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-23
• Last Update Posted: 2021-04-26

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 154

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
PTCA - Desolve Scaffold	PTCA - Desolve Scaffold	Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold

Primary Outcome Measures

Name	Time	Method
MI	12 months	Myocardial Infarction
TLF (Target Lesion Failure)	12 months	TLF is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)
Death	12 months	All cause mortality
CD-TVR	12 months	Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)
CABG	12 months	Emergency bypass surgery (CABG)

Secondary Outcome Measures

Name	Time	Method
MACE	3 years	MACE is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)
Device Success	day of treatment procedure	Successful delivery and deployment of the Clinical Investigation scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis \< 50% by QCA (by visual estimation if QCA is unavailable). Standard pre-dilation catheters and post-dilatation catheters (if applicable) may be used. Bailout subjects will be included as device success only if the above criteria for clinical device success are met
Procedure Success	30 days	Successful delivery and deployment of the DESolve scaffold at the target lesion and successful withdrawal of the scaffold delivery system with attainment of final residual stenosis of \< 50% by QCA (by visual estimation if QCA unavailable) and/or using any adjunctive device without the occurrence of ischemia driven major adverse cardiac event (MACE) during the hospital stay with a maximum of first seven days post index procedure.
Thrombosis	12 months	Thrombosis: The ARC stent thrombosis criteria are applied

Trial Locations

Locations (5)

Krankenhaus der Barmherzigen Brüder; 🇩🇪 Trier, Germany

St. Antonius Ziekenhuis; 🇳🇱 Nieuwegein, Netherlands

Universitätsklinikum Giessen; 🇩🇪 Giessen, Germany

Kerckhoff-Klinik; 🇩🇪 Bad Nauheim, Germany

GPR Klinikum Rüsselsheim; 🇩🇪 Rüsselsheim, Germany