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Status:

ACTIVE_NOT_RECRUITING

XIENCE Skypoint Large Vessel Post Approval Study

Lead Sponsor:

Abbott Medical Devices

Conditions:

Coronary Artery Disease

Eligibility:

All Genders

18+ years

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 Everolimu...

Eligibility Criteria

Inclusion

  • General Inclusion Criteria
  • Subject must be at least 18 years of age.
  • Subject or a legally authorized representative must provide written informed consent per site requirements.
  • 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:
  • Abnormal stress or imaging stress test
  • Abnormal computed tomography-fractional flow reserve (CT-FFR)
  • Stenosis by visual estimation ≥ 70%
  • Abnormal pressure-derived indexes (FFR, instantaneous wave-free ratio \[iFR\], or relative flow reserve \[RFR\])
  • Subject must agree not to participate in any other clinical study for a period of one year following the index procedure.
  • Angiographic Inclusion Criteria
  • Patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion
  • Patients who receive at least one Skypoint LV stent
  • 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
  • Up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure.

Exclusion

  • General Exclusion Criteria
  • Patients who have contraindications of the Skypoint LV per the IFU
  • 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

Key Trial Info

Start Date :

September 14 2022

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

August 30 2027

Estimated Enrollment :

102 Patients enrolled

Trial Details

Trial ID

NCT05423379

Start Date

September 14 2022

End Date

August 30 2027

Last Update

January 8 2025

Active Locations (18)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (18 locations)

1

Arkansas Heart Hospital

Little Rock, Arkansas, United States, 72211

2

Memorial Hospital Jacksonville

Jacksonville, Florida, United States, 32216

3

Tallahassee Research Institute

Tallahassee, Florida, United States, 32308

4

Via Christi Regional Medical Center - St. Francis Campus

Wichita, Kansas, United States, 67226