DESolve® X-Pand Global Post Market Registry

Coronary Artery Stenosis Clinical Trial

— X-Pand  

Official title:

X-Pand is Intended to Use the DESolve Scaffold System in Treatment of CAD Patients, by Including "Real World" Use of the DESolve Scaffold Over a Broad Spectrum of Geographies, A Wide Variety of Practicing Clinicians & A Minimum Degree Of Selection Criteria

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02453035
• Other study ID #: ELX-CL-1503
• Status: Terminated
• Start date: May 13, 2015
• Est. completion date: April 30, 2017

Study information

• Verified date: April 2021
• Source: Elixir Medical Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 154
• Est. completion date: April 30, 2017
• Est. primary completion date: March 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Stenosis
• Coronary Stenosis

Intervention

Device:
• PTCA - Desolve Scaffold
Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold

Locations

Country	Name	City	State
Germany	Kerckhoff-Klinik	Bad Nauheim
Germany	Universitätsklinikum Giessen	Giessen
Germany	GPR Klinikum Rüsselsheim	Rüsselsheim
Germany	Krankenhaus der Barmherzigen Brüder	Trier
Netherlands	St. Antonius Ziekenhuis	Nieuwegein

Sponsors (2)

Lead Sponsor	Collaborator
Elixir Medical Corporation	European Cardiovascular Research Center

Countries where clinical trial is conducted

Germany,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TLF (Target Lesion Failure)	TLF is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)	12 months
Primary	Death	All cause mortality	12 months
Primary	MI	Myocardial Infarction	12 months
Primary	CABG	Emergency bypass surgery (CABG)	12 months
Primary	CD-TVR	Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)	12 months
Secondary	Thrombosis	Thrombosis: The ARC stent thrombosis criteria are applied	12 months
Secondary	Device Success	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	day of treatment procedure
Secondary	Procedure Success	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.	30 days
Secondary	MACE	MACE is defined as: cardiac death, MI not clearly attributable to a non-intervention vessel, and clinically-indicated target lesion revascularization (TLR)	3 years