← Back to Search

Drug-Eluting Stent

XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System for Coronary Artery Disease (SPIRIT XLV PAS Trial)

N/A
Waitlist Available
Research Sponsored by Abbott Medical Devices
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 1 year
Awards & highlights

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.

Eligible Conditions
  • Coronary Artery Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with Target Lesion Failure (TLF) at 1 year

Side effects data

From 2018 Phase 3 trial • 106 Patients • NCT01544491
30%
Diarrhoea
28%
Urinary tract infection
20%
Pyrexia
20%
Headache
20%
Anaemia
19%
Neutropenia
19%
Cough
15%
Vomiting
15%
BK virus infection
15%
Tonsillitis
11%
Hypertension
11%
Nasopharyngitis
11%
Leukopenia
11%
Abdominal pain
11%
Upper respiratory tract infection
11%
Blood creatinine increased
9%
Ear infection
9%
Gastroenteritis
9%
Ear pain
9%
Abdominal pain upper
9%
Rhinitis
9%
Weight decreased
7%
Pruritus
7%
Hypomagnesaemia
7%
Nausea
7%
Bronchitis
7%
Vitamin D deficiency
7%
Tremor
6%
Cytomegalovirus infection
6%
Cytomegalovirus viraemia
6%
Pain
6%
Oral herpes
6%
Acidosis
6%
Obesity
6%
Skin papilloma
6%
Sinusitis
6%
Haematuria
6%
Oropharyngeal pain
4%
Epstein-Barr viraemia
4%
Epstein-Barr virus infection
4%
Hypertriglyceridaemia
4%
Rash
4%
Constipation
4%
Mouth ulceration
4%
Fatigue
4%
Weight increased
4%
Proteinuria
2%
Hypokalaemia
2%
Aphthous ulcer
2%
Cystitis
2%
Influenza
2%
Otitis media
2%
Pharyngitis
2%
Hepatic enzyme increased
2%
Pain in extremity
100%
80%
60%
40%
20%
0%
Study treatment Arm
MMF+sTAC
EVR+rTAC

Trial Design

1Treatment groups
Experimental Treatment
Group I: XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent SystemExperimental Treatment1 Intervention
Subjects who were implanted with XIENCE Skypoint Large Vessel Everolimus Eluting Coronary Stent System will be included.

Find a Location

Who is running the clinical trial?

Abbott Medical DevicesLead Sponsor
647 Previous Clinical Trials
408,432 Total Patients Enrolled
103 Trials studying Coronary Artery Disease
126,900 Patients Enrolled for Coronary Artery Disease
~32 spots leftby Aug 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top