Registry to Assess the STENTYS Xposition S for Revascularization of Coronary Arteries In Routine cliNical Practice (WIN)

Stentys

Status: Unknown

Conditions: Coronary Self Expanding Stent

Treatments: Device: PCI

Study type: Observational

Funder types: Industry

Identifiers

NCT03115281

ST2016-02

Details and patient eligibility

About

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.

Full 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.

Enrollment: 750 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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:
  4. Ostial left main lesion;
  5. Presence of severe calcifications
  6. Vessel diameter is smaller than 3.0mm