Study Stopped
slow enrollment due to change in worldwide scaffold usage
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
1 other identifier
observational
154
2 countries
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started May 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 13, 2015
CompletedStudy Start
First participant enrolled
May 13, 2015
CompletedFirst Posted
Study publicly available on registry
May 25, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 30, 2017
CompletedApril 26, 2021
April 1, 2021
1.9 years
May 13, 2015
April 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
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
MI
Myocardial Infarction
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 Outcomes (4)
Thrombosis
12 months
Device Success
day of treatment procedure
Procedure Success
30 days
MACE
3 years
Study Arms (1)
PTCA - Desolve Scaffold
Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold
Interventions
Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold
Eligibility Criteria
patients who have received implants of one or more DESolve scaffold(s)
You may qualify if:
- Minimal age 18 years
- 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).
- Planned or unplanned DESolve scaffold implantation
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Kerckhoff-Klinik
Bad Nauheim, 61231, Germany
Universitätsklinikum Giessen
Giessen, 35392, Germany
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, 65428, Germany
Krankenhaus der Barmherzigen Brüder
Trier, 54292, Germany
St. Antonius Ziekenhuis
Nieuwegein, 3430, Netherlands
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean Fajadet, Dr.
University Hospital of Toulouse
- PRINCIPAL INVESTIGATOR
Holger Nef, Prof Dr.
Universitätsklinikum Giessen und Marburg
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 13, 2015
First Posted
May 25, 2015
Study Start
May 13, 2015
Primary Completion
March 31, 2017
Study Completion
April 30, 2017
Last Updated
April 26, 2021
Record last verified: 2021-04