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

NCT03115281 | Unknown

• 1 other identifier: ST2016-02
• Study Type: observational
• Target: 750
• Locations: 2 countries
• Sites: 2

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.

Conditions

Coronary Self Expanding Stent

Outcome Measures

Primary Outcomes (1)

• 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)

  1 year follow-up post-procedure

Secondary Outcomes (4)

• TLF at 2 Year

  2 year follow-up post-procedure

• TVF at 1 Year

  1 year follow-up post-procedure

• Acute success rates

  From Index procedure up to hospital discharge (48 hours post procedure)

• Stent thrombosis

  1-year and 2-year follow-up post procedure

Interventions

PCI DEVICE

PCI

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• Known pregnancy or breastfeeding; 2. Known contraindication or hypersensitivity to any stent components, any PCI-related material or drug.
• \. 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

Sponsors & Collaborators

• Stentys: lead

Study Sites (2)

OLVG

Amsterdam, Netherlands

NOT YET RECRUITING

Kantonsspital

Sankt Gallen, Switzerland

RECRUITING

Central Study Contacts

David Bouchez

CONTACT

+33 1 44 53 99 42; david.bouchez@stentys.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2017
• First Posted: April 14, 2017
• Study Start: March 20, 2017
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2020
• Last Updated: May 4, 2017

Record last verified: 2017-05

Locations

NL (1); CH (1)