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

NCT ID: NCT03115281

Last Updated: 2017-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 750 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-20
• Study Completion Date: 2020-07-31

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.

Conditions

Coronary Self Expanding Stent

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

PCI

PCI

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Stentys

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

OLVG

Amsterdam, , Netherlands

Site Status: NOT_YET_RECRUITING

Kantonsspital

Sankt Gallen, , Switzerland

Site Status: RECRUITING

Countries

Netherlands; Switzerland

Central Contacts

David Bouchez

Role: CONTACT

david.bouchez@stentys.com

+33 1 44 53 99 42

Facility Contacts

Giovanni Amoroso

Role: primary

Daniel Weilenmann

Role: primary

Other Identifiers

ST2016-02

Identifier Type: -

Identifier Source: org_study_id