XIENCE Skypoint Large Vessel Post Approval Study

Coronary Artery Disease Clinical Trial

— SPIRIT XLV PAS  

Official title:

XIENCE Skypoint Large Vessel Post Approval Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05423379
• Other study ID #: ABT -CIP 10445
• Status: Active, not recruiting
• Start date: September 14, 2022
• Est. completion date: August 30, 2027

Study information

• Verified date: November 2023
• Source: Abbott Medical Devices
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 real-world setting.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 102
• Est. completion date: August 30, 2027
• Est. primary completion date: August 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

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.

Locations

Country	Name	City	State
France	Hopital Cardiovasculaire et Pneumologique Louis Pradel	Lyon	Rhone
France	Clinique Pasteur Toulouse	Toulouse	Midi-Pyrenees
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander
Spain	Hospital Virgen de Rocio	Sevilla
United States	Hendrick Medical Center	Abilene	Texas
United States	Anmed Health	Anderson	South Carolina
United States	Austin Heart	Austin	Texas
United States	Greenville Health System	Greenville	South Carolina
United States	Memorial Hospital Jacksonville	Jacksonville	Florida
United States	Bryan Heart	Lincoln	Nebraska
United States	Arkansas Heart Hospital	Little Rock	Arkansas
United States	Lenox Hill Hospital	New York	New York
United States	St. Francis Hospital	New York	New York
United States	The Heart Hospital Baylor Plano	Plano	Texas
United States	Shannon Clinic	San Angelo	Texas
United States	UCLA Medical Center Santa Monica	Santa Monica	California
United States	HonorHealth	Scottsdale	Arizona
United States	Tallahassee Research Institute	Tallahassee	Florida
United States	Los Robles Regional Medical Center	Thousand Oaks	California
United States	Via Christi Regional Medical Center - St. Francis Campus	Wichita	Kansas
United States	Pinnacle Health System	Wormleysburg	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Abbott Medical Devices

Countries where clinical trial is conducted

United States,  France,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants with Target Lesion Failure (TLF) 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).	At 1 Year