Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
102 participants
OBSERVATIONAL
2022-09-14
2027-08-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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.
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
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.
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.
18 Years
ALL
No
Sponsors
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Abbott Medical Devices
INDUSTRY
Responsible Party
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Locations
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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
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
Hospital Virgen de Rocio
Seville, , Spain
Countries
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Other Identifiers
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ABT -CIP 10445
Identifier Type: -
Identifier Source: org_study_id
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