DESolve® X-Pand Global Post Market Registry (X-Pand)

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

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.

Study Overview

• Status: Terminated
• Conditions: Coronary Artery Stenosis
• Intervention / Treatment: Device: PTCA - Desolve Scaffold

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 Type: Observational
• Enrollment (Actual): 154

Contacts and Locations

Study Locations

• Germany
  • Bad Nauheim, Germany, 61231
    • Kerckhoff-Klinik
  • Giessen, Germany, 35392
    • Universitätsklinikum Gießen
  • Rüsselsheim, Germany, 65428
    • GPR Klinikum Rüsselsheim
  • Trier, Germany, 54292
    • Krankenhaus der Barmherzigen Brüder
• Netherlands
  • Nieuwegein, Netherlands, 3430
    • St. Antonius Ziekenhuis

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients who have received implants of one or more DESolve scaffold(s)

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PTCA - Desolve Scaffold; Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold	Device: PTCA - Desolve Scaffold; Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold; Other Names: PTA. PCI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
MI	Myocardial Infarction	12 months
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
Death	All cause mortality	12 months
CABG	Emergency bypass surgery (CABG)	12 months
CD-TVR	Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Thrombosis	Thrombosis: The ARC stent thrombosis criteria are applied	12 months
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
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
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

Collaborators and Investigators

• Sponsor: Elixir Medical Corporation
• Collaborators: European Cardiovascular Research Center
• Investigators: Principal Investigator: Jean Fajadet, Dr., University Hospital of Toulouse; Principal Investigator: Holger Nef, Prof Dr., Universitätsklinikum Giessen und Marburg

Study record dates

Study Major Dates

• Study Start (Actual): May 13, 2015
• Primary Completion (Actual): March 31, 2017
• Study Completion (Actual): April 30, 2017

Study Registration Dates

• First Submitted: May 13, 2015
• First Submitted That Met QC Criteria: May 20, 2015
• First Posted (Estimate): May 25, 2015

Study Record Updates

• Last Update Posted (Actual): April 26, 2021
• Last Update Submitted That Met QC Criteria: April 23, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: CAD; bioresorbable scaffold
• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Coronary Stenosis
• Other Study ID Numbers: ELX-CL-1503