XIENCE Skypoint Large Vessel Post Approval Study

Active, not recruiting

• Conditions: Coronary Artery Disease
• Interventions: Device: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System (EECSS)

• Registration Number: NCT05423379
• Lead Sponsor: Abbott Medical Devices

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-06-15
• Study First Submitted QC: 2022-06-15
• Study First Posted: 2022-06-21
• Study Start: 2022-09-14
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-07
• Last Update Posted: 2025-01-08
• Primary Completion: 2025-08-30
• Study Completion: 2027-08-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 102

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System	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.

Primary Outcome Measures

Name	Time	Method
Number of participants with Target Lesion Failure (TLF) at 1 year	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).

Trial Locations

Locations (18)

Arkansas Heart Hospital; 🇺🇸 Little Rock, Arkansas, United States

Memorial Hospital Jacksonville; 🇺🇸 Jacksonville, Florida, United States

Tallahassee Research Institute; 🇺🇸 Tallahassee, Florida, United States

Via Christi Regional Medical Center - St. Francis Campus; 🇺🇸 Wichita, Kansas, United States

Bryan Heart; 🇺🇸 Lincoln, Nebraska, United States

Lenox Hill Hospital; 🇺🇸 New York, New York, United States

Pinnacle Health System; 🇺🇸 Wormleysburg, Pennsylvania, United States

Anmed Health; 🇺🇸 Anderson, South Carolina, United States

Greenville Health System; 🇺🇸 Greenville, South Carolina, United States

Hendrick Medical Center; 🇺🇸 Abilene, Texas, United States

Austin Heart; 🇺🇸 Austin, Texas, United States

The Heart Hospital Baylor Plano; 🇺🇸 Plano, Texas, United States

Hospital Virgen de Rocio; 🇪🇸 Sevilla, Spain

Shannon Clinic; 🇺🇸 San Angelo, Texas, United States

Clinique Pasteur Toulouse; 🇫🇷 Toulouse, Midi-Pyrenees, France

Hopital Cardiovasculaire et Pneumologique Louis Pradel; 🇫🇷 Lyon, Rhone, France

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain

Hospital Universitario Marqués de Valdecilla; 🇪🇸 Santander, Spain