Clinical trial NCT05423379: XIENCE Skypoint Large Vessel Post Approval Study
Official title: XIENCE Skypoint Large Vessel Post Approval Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Coronary Artery Disease
Keywords: ABT -CIP 10445
Coronary artery disease
XIENCE
Large Vessel
Skypoint
Lead sponsor: Abbott Medical Devices
Sponsor class: INDUSTRY
First posted: 2022-06-21
Enrollment: 102
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects of all genders from the general population who have at least one XIENCE Skypoint LV implanted.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Number of participants with Target Lesion Failure (TLF) at 1 year
timeFrame: At 1 Year
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Heart Hospital
state: Arkansas
city: Jacksonville
country: United States
facility: Memorial Hospital Jacksonville
state: Florida
city: Tallahassee
country: United States
facility: Tallahassee Research Institute
state: Florida
city: Wichita
country: United States
facility: Via Christi Regional Medical Center - St. Francis Campus
state: Kansas
city: Lincoln
country: United States
facility: Bryan Heart
state: Nebraska
city: New York
country: United States
facility: Lenox Hill Hospital
state: New York
city: Wormleysburg
country: United States
facility: Pinnacle Health System
state: Pennsylvania
city: Anderson
country: United States
facility: Anmed Health
state: South Carolina
city: Greenville
country: United States
facility: Greenville Health System
state: South Carolina
city: Abilene
country: United States
facility: Hendrick Medical Center
state: Texas
city: Austin
country: United States
facility: Austin Heart
state: Texas
city: Plano
country: United States
facility: The Heart Hospital Baylor Plano
state: Texas
city: San Angelo
country: United States
facility: Shannon Clinic
state: Texas
city: Toulouse
country: France
facility: Clinique Pasteur Toulouse
state: Midi-Pyrenees
city: Lyon
country: France
facility: Hopital Cardiovasculaire et Pneumologique Louis Pradel
state: Rhone
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Virgen de Rocio
Study officials:
References: