XIENCE Skypoint Large Vessel Post Approval Study

Running, not enrolling

Conditions studied: Coronary Artery Disease

In brief

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.

Key facts

Study ID

NCT05423379

Run by

Abbott Medical Devices

People needed

102

Starts

2022-09-14

Expected to finish

2027-08-30

Last updated by the study team

2026-02-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• General Inclusion Criteria
• Subject must be at least 18 years of age.
• Subject or a legally authorized representative must provide written informed consent per site requirements.
• 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:
• Abnormal stress or imaging stress test
• Abnormal computed tomography-fractional flow reserve (CT-FFR)
• Stenosis by visual estimation ≥ 70%
• Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio [iFR], or relative flow reserve [RFR])
• Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
• Angiographic Inclusion Criteria
• Patients who have lesion(s) in a vessel with reference vessel diameter > 4.25 mm and ≤ 5.25 mm as the target lesion
• Patients who receive at least one Skypoint LV stent
• 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
• Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.

You may not qualify if…

• General Exclusion Criteria
• Patients who have contraindications of the Skypoint LV per the IFU
• 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:
• Patients who require three vessel treatment.
• If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23
• 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
• 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.

Where it is running

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

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.