Trials / Active Not Recruiting
Active Not RecruitingNCT05423379
XIENCE Skypoint Large Vessel Post Approval Study
- Status
- Active Not Recruiting
- Phase
- —
- Study type
- Observational
- Enrollment
- 102 (actual)
- Sponsor
- Abbott Medical Devices · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | 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. |
Timeline
- Start date
- 2022-09-14
- Primary completion
- 2024-11-20
- Completion
- 2027-08-30
- First posted
- 2022-06-21
- Last updated
- 2026-02-24
- Results posted
- 2026-02-24
Locations
18 sites across 3 countries: United States, France, Spain
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05423379. Inclusion in this directory is not an endorsement.