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)
Descriptive Primary Endpoint: Target Lesion Failure (TLF) — At 1 Year TLF is defined as the composite of cardiac death, myocardial infarction related to the target vessel (TV-MI), or ischemic driven target lesion revascularization (ID-TLR).
Trial sites (18)
Facility
City
Region
Status
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.
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