Clinical trial NCT03115281: Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
Official title: World-wide Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Self Expanding Stent
Lead sponsor: Stentys
Sponsor class: INDUSTRY
First posted: 2017-04-14
Enrollment: 750
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥18 years;
2. Presence of de novo coronary artery stenosis of ≥50% in a coronary artery suitable for implantation of the XPOSITION S STENT;
3. Vessel reference vessel diameter \> 2.5 mm and ≤ 6.0 mm without excessive tortuosity or diffuse distal disease;
4. The target lesion is suitable for a drug-eluting self-expanding stent indication, as assessed by investigator;
5. The target lesion is 10mm or longer;
6. The patient has been fully informed of the study, written informed consent as approved by the applicable Ethics Committee.

Exclusion Criteria:

* 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:
  1. Ostial left main lesion;
  2. Presence of severe calcifications
  3. Vessel diameter is smaller than 3.0mm

Primary outcomes:
measure: TLF at 1 Year follow-up
timeFrame: 1 year follow-up post-procedure
Secondary outcomes:
measure: TLF at 2 Year
timeFrame: 2 year follow-up post-procedure
measure: TVF at 1 Year
timeFrame: 1 year follow-up post-procedure
measure: Acute success rates
timeFrame: From Index procedure up to hospital discharge (48 hours post procedure)
measure: Stent thrombosis
timeFrame: 1-year and 2-year follow-up post procedure
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: OLVG
city: St. Gallen
country: Switzerland
facility: Kantonsspital
Study officials:
References: