Coronary Self Expanding StentWINNCT03115281
Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
An observational study of Coronary Self Expanding Stent, run by Stentys at 2 sites in 2 countries.
Trial summary
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Self Expanding Stent
- What is being tested?
- PCI
- Type of treatment
- Medical device
- How many people
- 750 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 20 Mar 2017to Jul 2020
- 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: Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for Percutaneous Coronary Interventions suitable for a self-expanding drug eluting stent. Patient must be over legal age, and sign an authorization form for collection, transfer and processing of personal data.
Who may be able to join
- Age ≥18 years;
- Presence of de novo coronary artery stenosis of ≥50% in a coronary artery suitable for implantation of the XPOSITION S STENT;
- Vessel reference vessel diameter > 2.5 mm and ≤ 6.0 mm without excessive tortuosity or diffuse distal disease;
- The target lesion is suitable for a drug-eluting self-expanding stent indication, as assessed by investigator;
- The target lesion is 10mm or longer;
- The patient has been fully informed of the study, written informed consent as approved by the applicable Ethics Committee.
Who cannot join
- Known pregnancy or breastfeeding; 2. Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
- 3. Concurrent medical condition with a life expectancy < 12 months; 4. Currently participating in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with this study endpoints; 5. Subjects undergoing cardiopulmonary resuscitation or in cardiogenic shock 6. Treatment of in-stent restenosis at target lesion; 7. Use of bioabsorbable/bioresorbable stents 8. Target lesion in left main coronary artery is excluded only if any of the following conditions is met:
- Ostial left main lesion;
- Presence of severe calcifications
- Vessel diameter is smaller than 3.0mm
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Netherlands1 site, 1 recruiting
- Not yet recruiting
OLVG
Amsterdam
Giovanni Amoroso
Switzerland1 site, 1 recruiting
- Recruiting
Kantonsspital
Sankt Gallen
Daniel Weilenmann
About this study
Official title: World-wide Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.
Read the detailed description
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S stent used in routine clinical practice. Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for elective percutaneous coronary interventions suitable for a self-expanding stent, can be included in the registry.
This registry will allow collecting data, and provide substantial information in a real world setting on patients with indications like lesions in vessels with diameter variance, large vessels, left main coronary artery, bifurcations, ectatic vessels, ...
WIN will enroll 750 patients from approximately 30 sites.
- Conditions
- Coronary Self Expanding Stent
- Being tested
- PCI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PCIDevice
PCI
What is being measured
The primary outcome is the main question the study is designed to answer.
TLF at 1 Year follow-up
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR)
Measured: 1 year follow-up post-procedure
Secondary outcomes (4)
TLF at 2 Year
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion
Measured: 2 year follow-up post-procedure
TVF at 1 Year
Target Vessel Failure (TVF) defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically indicated Target Vessel Revascularization (TVR),
Measured: 1 year follow-up post-procedure
Acute success rates
- Device Success: Attainment of < 20% final in-stent residual stenosis of the target lesion with the XPOSITION S;
- Lesion Success: Attainment of < 20% final in-stent residual stenosis of the target lesion using any percutaneous method;
- Procedure Success: TIMI grade 3 and no in-hospital MACE
Measured: From Index procedure up to hospital discharge (48 hours post procedure)
Stent thrombosis
Stent thrombosis (definite/probable) - Academic Research Consortium (ARC) definition
Measured: 1-year and 2-year follow-up post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2017
- Study start20 Mar 2017
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Self Expanding StentStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Stentys
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03115281
- Sponsor's protocol ID
- ST2016-02
- Acronym
- WIN
- Status last verified
- May 2017
- First submitted
- 24 Mar 2017
- Last updated
- 4 May 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- World-wide Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
- ClinicalTrials.gov ID
- NCT03115281
- Acronym / sponsor ID
- WIN / ST2016-02
- Conditions
- Coronary Self Expanding Stent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- StentysIndustry (pharma, biotech, devices)
- Study start
- 20 Mar 2017 (actual)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 14 Apr 2017 (actual)
- 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.
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S STENT used in routine clinical practice.
Detailed description
WIN is a prospective, observational multinational post-marketing registry designed to evaluate the safety and effectiveness of the XPOSITION S stent used in routine clinical practice. Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for elective percutaneous coronary interventions suitable for a self-expanding stent, can be included in the registry.
This registry will allow collecting data, and provide substantial information in a real world setting on patients with indications like lesions in vessels with diameter variance, large vessels, left main coronary artery, bifurcations, ectatic vessels, ...
WIN will enroll 750 patients from approximately 30 sites.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects with coronary artery disease, including patients with chronic stable angina, silent ischemia and acute coronary syndrome, who qualify for Percutaneous Coronary Interventions suitable for a self-expanding drug eluting stent. Patient must be over legal age, and sign an authorization form for collection, transfer and processing of personal data.
Key inclusion criteria (6 listed)
- Age ≥18 years;
- Presence of de novo coronary artery stenosis of ≥50% in a coronary artery suitable for implantation of the XPOSITION S STENT;
- Vessel reference vessel diameter > 2.5 mm and ≤ 6.0 mm without excessive tortuosity or diffuse distal disease;
- The target lesion is suitable for a drug-eluting self-expanding stent indication, as assessed by investigator;
- The target lesion is 10mm or longer;
Key exclusion criteria (5 listed)
- Known pregnancy or breastfeeding; 2. Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
- 3. Concurrent medical condition with a life expectancy < 12 months; 4. Currently participating in another investigational device or drug trial that has not completed the primary endpoint or that clinically interferes with this study endpoints; 5. Subjects undergoing cardiopulmonary resuscitation or in cardiogenic shock 6. Treatment of in-stent restenosis at target lesion; 7. Use of bioabsorbable/bioresorbable stents 8. Target lesion in left main coronary artery is excluded only if any of the following conditions is met:
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 |
|---|---|---|
| PCIPCI | Device | – |
Primary outcome
TLF at 1 Year follow-up
Time frame: 1 year follow-up post-procedure
Target Lesion Failure (TLF), defined as cardiac death, Myocardial Infarction (MI) attributable to the Target Vessel (TV), clinically driven Target Lesion Revascularization (TLR)
4 secondary outcomes
TLF at 2 Year
Time frame: 2 year follow-up post-procedure
TVF at 1 Year
Time frame: 1 year follow-up post-procedure
Acute success rates
Time frame: From Index procedure up to hospital discharge (48 hours post procedure)
Stent thrombosis
Time frame: 1-year and 2-year follow-up post procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2017.
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.
2 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 Self Expanding Stent, run by Stentys at 2 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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 4 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Netherlands, Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact David Bouchez (+33 1 44 53 99 42, david.bouchez@stentys.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TLF at 1 Year follow-up (time frame: 1 year follow-up post-procedure). 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 4 May 2017.