XIENCE Skypoint Large Vessel Post Approval Study
a study on Coronary Artery Disease Peripheral Artery Disease Heart Disease
Summary
- Eligibility
- for people ages 18 years and up (full criteria)
- Location
- at UCLA
- Dates
- study startedcompletion around
Description
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.
Keywords
Coronary Artery Disease, ABT -CIP 10445, XIENCE, Large Vessel, Skypoint, Myocardial Ischemia, Coronary Disease, Everolimus, XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS), XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System
Eligibility
You can join if…
Open to people ages 18 years and up
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 CAN'T join 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.
Locations
- UCLA Medical Center Santa Monica
Santa Monica California 90404 United States - Los Robles Regional Medical Center
Thousand Oaks California 91360 United States
Details
- Status
- in progress, not accepting new patients
- Start Date
- Completion Date
- (estimated)
- Sponsor
- Abbott Medical Devices
- ID
- NCT05423379
- Study Type
- Observational
- Participants
- About 102 people participating
- Last Updated