Coronary Artery StenosisX-PandNCT02453035
DESolve® X-Pand Global Post Market Registry
An observational study of Coronary Artery Stenosis, run by Elixir Medical Corporation at 5 sites in 2 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Stenosis
- What is being tested?
- PTCA - Desolve Scaffold
- Type of treatment
- Medical device
- How many people
- 154 participants
- Where
- 5 sitesin 2 countries
- Study dates
- 13 May 2015to 30 Apr 2017
- How long will I take part?
- 3 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients who have received implants of one or more DESolve scaffold(s)
Who may be able to join
- 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
Who cannot join
- None
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Germany4 sites
Kerckhoff-Klinik
Bad Nauheim, 61231
Universitätsklinikum Giessen
Giessen, 35392
GPR Klinikum Rüsselsheim
Rüsselsheim am Main, 65428
Krankenhaus der Barmherzigen Brüder
Trier, 54292
About this study
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
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.
Read the 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.
- Conditions
- Coronary Artery Stenosis
- Being tested
- PTCA - Desolve Scaffold
- Keywords
- bioresorbable scaffold, CAD
- Medical subject headings
- Coronary Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PTCA - Desolve ScaffoldDevice
Also called PTA. PCI
Percutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold
| Study group | Role | What they receive |
|---|---|---|
| PTCA - Desolve Scaffold | Patients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold Receives: Device: PTCA - Desolve Scaffold |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 12 months
Death
All cause mortality
Measured: 12 months
MI
Myocardial Infarction
Measured: 12 months
CABG
Emergency bypass surgery (CABG)
Measured: 12 months
CD-TVR
Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)
Measured: 12 months
Secondary outcomes (4)
Thrombosis
Thrombosis: The ARC stent thrombosis criteria are applied
Measured: 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
Measured: 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.
Measured: 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)
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2015 (estimated)
- Study start13 May 2015
- Primary completion31 Mar 2017
- Study completion30 Apr 2017
Why it stopped: slow enrollment due to change in worldwide scaffold usage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 154 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Elixir Medical Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Responsible party
- Sponsor
- Investigators
- Jean Fajadet, Dr., Principal investigator, University Hospital of ToulouseHolger Nef, Prof Dr., Principal investigator, University Hospital Giessen and Marburg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02453035
- Sponsor's protocol ID
- ELX-CL-1503
- Acronym
- X-Pand
- Status last verified
- Apr 2021
- First submitted
- 13 May 2015
- Last updated
- 26 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02453035
- Acronym / sponsor ID
- X-Pand / ELX-CL-1503
- Conditions
- Coronary Artery Stenosis
- Keywords
- bioresorbable scaffold, CAD
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: slow enrollment due to change in worldwide scaffold usage
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Elixir Medical CorporationIndustry (pharma, biotech, devices)
- Collaborators
- European Cardiovascular Research Center
- Study start
- 13 May 2015 (actual)
- Primary completion
- 31 Mar 2017 (actual)
- Study completion
- 30 Apr 2017 (actual)
- First posted
- 25 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTCA - Desolve Scaffold | – | Device: PTCA - Desolve ScaffoldPatients with coronary artery stenosis who have been treated with a DESolve bioresorbable coronary scaffold |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients who have received implants of one or more DESolve scaffold(s)
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PTCA - Desolve ScaffoldAlso: PTA. PCIPercutaneous Coronary Artery Intervention with a DESolve bioresorbable coronary scaffold | Device | PTCA - Desolve Scaffold |
Primary outcome
TLF (Target Lesion Failure)
Time frame: 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
Time frame: 12 months
All cause mortality
MI
Time frame: 12 months
Myocardial Infarction
CABG
Time frame: 12 months
Emergency bypass surgery (CABG)
CD-TVR
Time frame: 12 months
Clinically-driven revascularization of the target vessel (Target Vessel Revascularization, TVR) using percutaneous or surgical methods (CABG)
4 secondary outcomes
Thrombosis
Time frame: 12 months
Device Success
Time frame: day of treatment procedure
Procedure Success
Time frame: 30 days
MACE
Time frame: 3 years
Results and safety
The study was stopped early (reason given: slow enrollment due to change in worldwide scaffold usage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jean Fajadet, Dr. principal investigator
University Hospital of Toulouse
Holger Nef, Prof Dr. principal investigator
University Hospital Giessen and Marburg
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Stenosis, run by Elixir Medical Corporation at 5 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 26 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Germany, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: slow enrollment due to change in worldwide scaffold usage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF (Target Lesion Failure) (time frame: 12 months). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Apr 2021.