XIENCE Skypoint Large Vessel Post Approval Study

NCT05423379 | Active Not Recruiting Results FDA Device

• 1 other identifier: ABT -CIP 10445
• Study Type: observational
• Target: 102
• Locations: 3 countries
• Sites: 18

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.

Conditions

Coronary Artery Disease

Keywords

ABT -CIP 10445; Coronary artery disease; XIENCE; Large Vessel; Skypoint

Outcome Measures

Primary Outcomes (1)

• 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).

  At 1 Year

Secondary Outcomes (1)

• Target Lesion Failure (TLFsp-MI) and Target Lesion Failure (TLFSCAI)

  1 year

Study Arms (1)

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.

Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)

Interventions

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.

XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.

You may qualify if:

• 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.
• 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:

• 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
• 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.

Sponsors & Collaborators

• Abbott Medical Devices: lead

Study Sites (18)

Arkansas Heart Hospital

Little Rock, Arkansas, 72211, United States

Location

Memorial Hospital Jacksonville

Jacksonville, Florida, 32216, United States

Location

Tallahassee Research Institute

Tallahassee, Florida, 32308, United States

Location

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, 67226, United States

Location

Bryan Heart

Lincoln, Nebraska, 68506, United States

Location

Lenox Hill Hospital

New York, New York, 10075, United States

Location

Pinnacle Health System

Wormleysburg, Pennsylvania, 17043, United States

Location

Anmed Health

Anderson, South Carolina, 29621, United States

Location

Greenville Health System

Greenville, South Carolina, 29605-5601, United States

Location

Hendrick Medical Center

Abilene, Texas, 79601, United States

Location

Austin Heart

Austin, Texas, 78756, United States

Location

The Heart Hospital Baylor Plano

Plano, Texas, 75074, United States

Location

Shannon Clinic

San Angelo, Texas, 76903, United States

Location

Clinique Pasteur Toulouse

Toulouse, Midi-Pyrenees, 31300, France

Location

Hopital Cardiovasculaire et Pneumologique Louis Pradel

Lyon, Rhone, France

Location

Hospital Clinico San Carlos

Madrid, Madrid, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Spain

Location

Hospital Virgen de Rocio

Seville, Spain

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Results Point of Contact

• Title: Vinuta Rau
• Organization: Abbott

vinuta.rau@abbott.com

+ 1 408-834-0621

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: September 14, 2022
• Primary Completion: November 20, 2024
• Study Completion (Estimated): August 30, 2027
• Last Updated: February 24, 2026
• Results First Posted: February 24, 2026

Record last verified: 2026-02

Locations

US (13); FR (2); ES (3)