Open
Actively Recruiting
XIENCE Skypoint Large Vessel Post Approval Study
About
Brief 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.
Study Type
Eligibility
Gender
Healthy Volunteers
Minimum Age
Maximum Age
Inclusion Criteria:
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.
Exclusion Criteria:
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.
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Study Stats
Protocol No.
22-001784
Category
Heart/Cardiovascular Diseases
Principal Investigator
Contact
Location
- UCLA Santa Monica
- UCLA Westwood