XIENCE Skypoint Large Vessel Post Approval Study (SPIRIT XLV PAS)

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 Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)

• Study Type: Observational
• Enrollment (Actual): 102

Contacts and Locations

Study Locations

• France
  • Midi-Pyrenees
    • Toulouse, Midi-Pyrenees, France, 31300
      • Clinique Pasteur Toulouse
  • Rhone
    • Lyon, Rhone, France
      • Hopital Cardiovasculaire et Pneumologique Louis Pradel
• Spain
  • Santander, Spain
    • Hospital Universitario Marques de Valdecilla
  • Seville, Spain
    • Hospital Virgen de Rocio
  • Madrid
    • Madrid, Madrid, Spain
      • Hospital Clinico San Carlos
• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Arkansas Heart Hospital
  • Florida
    • Jacksonville, Florida, United States, 32216
      • Memorial Hospital Jacksonville
    • Tallahassee, Florida, United States, 32308
      • Tallahassee Research Institute
  • Kansas
    • Wichita, Kansas, United States, 67226
      • Via Christi Regional Medical Center - St. Francis Campus
  • Nebraska
    • Lincoln, Nebraska, United States, 68506
      • Bryan Heart
  • New York
    • New York, New York, United States, 10075
      • Lenox Hill Hospital
  • Pennsylvania
    • Wormleysburg, Pennsylvania, United States, 17043
      • Pinnacle Health System
  • South Carolina
    • Anderson, South Carolina, United States, 29621
      • AnMed Health
    • Greenville, South Carolina, United States, 29605-5601
      • Greenville Health System
  • Texas
    • Abilene, Texas, United States, 79601
      • Hendrick Medical Center
    • Austin, Texas, United States, 78756
      • Austin Heart
    • Plano, Texas, United States, 75074
      • The Heart Hospital Baylor Plano
    • San Angelo, Texas, United States, 76903
      • Shannon Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

General Inclusion Criteria

1. Subject must be at least 18 years of age.
2. Subject or a legally authorized representative must provide written informed consent per site requirements.

3. 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:

   1. Abnormal stress or imaging stress test
   2. Abnormal computed tomography-fractional flow reserve (CT-FFR)
   3. Stenosis by visual estimation ≥ 70%
   4. Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio [iFR], or relative flow reserve [RFR])
4. Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.

Angiographic Inclusion Criteria

1. Patients who have lesion(s) in a vessel with reference vessel diameter > 4.25 mm and ≤ 5.25 mm as the target lesion

2. Patients who receive at least one Skypoint LV stent

   1. 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
   2. Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.

Exclusion Criteria:

General Exclusion Criteria

1. Patients who have contraindications of the Skypoint LV per the IFU
2. 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:

1. Patients who require three vessel treatment.

2. If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23

   1. 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
   2. 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Collaborators and Investigators

• Sponsor: Abbott Medical Devices

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2022
• Primary Completion (Actual): November 20, 2024
• Study Completion (Estimated): August 30, 2027

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): February 24, 2026
• Last Update Submitted That Met QC Criteria: February 19, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Coronary artery disease; ABT -CIP 10445; XIENCE; Large Vessel; Skypoint
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Heart Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Myocardial Ischemia; Coronary Artery Disease; MTOR Inhibitors; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Protein Kinase Inhibitors; Everolimus
• Other Study ID Numbers: ABT -CIP 10445

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No