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

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.

Study Overview

• Status: Unknown
• Conditions: Coronary Self Expanding Stent
• Intervention / Treatment: Device: PCI

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 Type: Observational
• Enrollment (Anticipated): 750

Contacts and Locations

Study Locations

• Netherlands
  • Amsterdam, Netherlands
    • Not yet recruiting
    • OLVG
    • Contact: Giovanni Amoroso
• Switzerland
  • St. Gallen, Switzerland
    • Recruiting
    • Kantonsspital
    • Contact: Daniel Weilenmann

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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),	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	From Index procedure up to hospital discharge (48 hours post procedure)
Stent thrombosis	Stent thrombosis (definite/probable) - Academic Research Consortium (ARC) definition	1-year and 2-year follow-up post procedure

Collaborators and Investigators

• Sponsor: Stentys

Study record dates

Study Major Dates

• Study Start (Actual): March 20, 2017
• Primary Completion (Anticipated): July 1, 2019
• Study Completion (Anticipated): July 1, 2020

Study Registration Dates

• First Submitted: March 24, 2017
• First Submitted That Met QC Criteria: April 10, 2017
• First Posted (Actual): April 14, 2017

Study Record Updates

• Last Update Posted (Actual): May 4, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: ST2016-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No