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Clinical Trials in the USA / NCT05423379
Active, not recruiting Observational

XIENCE Skypoint Large Vessel Post Approval Study

NCT05423379 · tracked via the Priya Life Science USA tracker
Sponsor
Abbott Medical Devices
Phase
Observational
Started
2022-09-14
Last updated
2026-02-24

Condition(s) studied

Coronary Artery Disease

Investigational drug(s) / intervention(s)

XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)

XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS): XIENCE Skypoint Large Vessel EECSS is composed of a L-605 CoCr stent and coated with poly (n-butyl methacrylate) (PBMA) primer and a drug coating formulation of polymer of vinylidene fluoride and hexafluoropropylene (PVDF-HFP)/everolimus pre-mounted on a balloon catheter delivery system.

Study summary

SPIRIT XLV PAS is a prospective, single arm, multi-center, US and OUS post-approval observational study to evaluate the continued safety and effectiveness of the XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) Large Vessel (LV) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: General Inclusion Criteria 1. Subject must be at least 18 years of age. 2. Subject or a legally authorized representative must provide written informed consent per site requirements. 3. Subject must have evidence of myocardial ischemia (STEMI, NSTEMI, Unstable Angina or Stable Angina) or who have silent ischemia with evidence of ischemia, appropriate for PCI treatment with DES. Subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following: 1. Abnormal stress or imaging stress test 2. Abnormal computed tomography-fractional flow reserve (CT-FFR) 3. Stenosis by visual estimation ≥ 70% 4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\]) 4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure. Angiographic Inclusion Criteria 1. Patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion 2. Patients who receive at least one Skypoint LV stent 1. Lesions with RVD ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available XIENCE family of stents 2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure. Exclusion Criteria: General Exclusion Criteria 1. Patients who have contraindications of the Skypoint LV per the IFU 2. Subject has active symptoms and/or a positive test result of COVID-19 or other rapidly spreading novel infectious agent within the prior 2 months. Angiographic Exclusion Criteria: 1. Patients who require three vessel treatment. 2. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23 1. Unprotected LM disease with a SYNTAX score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population 2. A heart team consensus approach per site's standard of care (SOC) to enhance patient protection and optimal clinical practice for the left main treatment is required.

Primary outcome measure(s)

Trial sites (18)

FacilityCityRegionStatus
Arkansas Heart Hospital Little Rock Arkansas
Memorial Hospital Jacksonville Jacksonville Florida
Tallahassee Research Institute Tallahassee Florida
Via Christi Regional Medical Center - St. Francis Campus Wichita Kansas
Bryan Heart Lincoln Nebraska
Lenox Hill Hospital New York New York
Pinnacle Health System Wormleysburg Pennsylvania
Anmed Health Anderson South Carolina
Greenville Health System Greenville South Carolina
Hendrick Medical Center Abilene Texas
Austin Heart Austin Texas
The Heart Hospital Baylor Plano Plano Texas
Shannon Clinic San Angelo Texas
Clinique Pasteur Toulouse Toulouse Midi-Pyrenees
Hopital Cardiovasculaire et Pneumologique Louis Pradel Lyon Rhone
Hospital Clinico San Carlos Madrid Madrid
Hospital Universitario Marqués de Valdecilla Santander Spain
Hospital Virgen de Rocio Seville Spain
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05423379 on ClinicalTrials.gov ↗ ← All trials in the USA