Coronary Artery DiseaseSPIRIT XLV PASNCT05423379
XIENCE Skypoint Large Vessel Post Approval Study
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 18 sites in 3 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)
- Type of treatment
- Medical device
- How many people
- 102 participants
- Where
- 18 sitesin 3 countries
- Study dates
- 14 Sep 2022to 30 Aug 2027
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.
Who may be able to join
- 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)
Show all 14Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
18 sites in 3 countries.
18 sites in 3 countries
United States13 sites
Hendrick Medical Center
Abilene, Texas, 79601
Anmed Health
Anderson, South Carolina, 29621
Austin Heart
Austin, Texas, 78756
Greenville Health System
Greenville, South Carolina, 29605-5601
Memorial Hospital Jacksonville
Jacksonville, Florida, 32216
Bryan Heart
Lincoln, Nebraska, 68506
Arkansas Heart Hospital
Little Rock, Arkansas, 72211
Lenox Hill Hospital
New York, New York, 10075
The Heart Hospital Baylor Plano
Plano, Texas, 75074
Shannon Clinic
San Angelo, Texas, 76903
Tallahassee Research Institute
Tallahassee, Florida, 32308
Via Christi Regional Medical Center - St. Francis Campus
Wichita, Kansas, 67226
Pinnacle Health System
Wormleysburg, Pennsylvania, 17043
Spain3 sites
Hospital Clinico San Carlos
Madrid, Madrid
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Virgen de Rocio
Seville
France2 sites
Hopital Cardiovasculaire et Pneumologique Louis Pradel
Lyon, Rhone
Clinique Pasteur Toulouse
Toulouse, Midi-Pyrenees, 31300
About this study
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
- Coronary Artery Disease
- Being tested
- XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)
- Keywords
- ABT -CIP 10445, Coronary artery disease, XIENCE, Large Vessel, Skypoint
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)Device
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 group | Role | What they receive |
|---|---|---|
| XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. Receives: Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Descriptive Primary Endpoint: Target Lesion Failure (TLF)
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).
Measured: At 1 Year
Secondary outcomes (1)
Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)
TLFsp-MI is defined as the composite of CD and TV-MI, including spontaneous MI and excluding periprocedural MI and, or ID-TLR. TLFSCAI is defined as the composite of CD and TV-MI, including both periprocedural MI and spontaneous MI, or ID-TLR.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2022
- Study start14 Sep 2022
- Primary completion20 Nov 2024
- Study completion30 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- More trials run by Abbott Medical DevicesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abbott Medical Devices
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05423379
- Sponsor's protocol ID
- ABT -CIP 10445
- Acronym
- SPIRIT XLV PAS
- Status last verified
- Feb 2026
- First submitted
- 15 Jun 2022
- Last updated
- 24 Feb 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- XIENCE Skypoint Large Vessel Post Approval Study
- ClinicalTrials.gov ID
- NCT05423379
- Acronym / sponsor ID
- SPIRIT XLV PAS / ABT -CIP 10445
- Conditions
- Coronary Artery Disease
- Keywords
- ABT -CIP 10445, Coronary artery disease, XIENCE, Large Vessel, Skypoint
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Abbott Medical DevicesIndustry (pharma, biotech, devices)
- Study start
- 14 Sep 2022 (actual)
- Primary completion
- 20 Nov 2024 (actual)
- Study completion
- 30 Aug 2027 (estimated)
- First posted
- 21 Jun 2022 (actual)
- Results
- Posted 24 Feb 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System | – | Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.
Key inclusion criteria (14 listed)
- 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:
- Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
Key exclusion criteria (8 listed)
- 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.
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System |
Primary outcome
Descriptive Primary Endpoint: Target Lesion Failure (TLF)
Time frame: 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).
1 secondary outcome
Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)
Time frame: 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
18 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Abbott Medical Devices at 18 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 24 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Spain, France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Descriptive Primary Endpoint: Target Lesion Failure (TLF) (time frame: At 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2026.