Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05423379
Other study ID # ABT -CIP 10445
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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.

Study Design


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
See also
  Status Clinical Trial Phase
Recruiting NCT06030596 - SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
Completed NCT04080700 - Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Recruiting NCT03810599 - Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study N/A
Recruiting NCT06002932 - Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions. N/A
Not yet recruiting NCT06032572 - Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE) N/A
Recruiting NCT04242134 - Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions N/A
Recruiting NCT05308719 - Nasal Oxygen Therapy After Cardiac Surgery N/A
Completed NCT04556994 - Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients. N/A
Recruiting NCT05846893 - Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease N/A
Recruiting NCT06027788 - CTSN Embolic Protection Trial N/A
Recruiting NCT05023629 - STunning After Balloon Occlusion N/A
Completed NCT04941560 - Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
Completed NCT04006288 - Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease Phase 4
Completed NCT01860274 - Meshed Vein Graft Patency Trial - VEST N/A
Recruiting NCT06174090 - The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients N/A
Completed NCT03968809 - Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
Terminated NCT03959072 - Cardiac Cath Lab Staff Radiation Exposure
Recruiting NCT04566497 - Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up. N/A
Recruiting NCT05065073 - Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography Phase 4
Completed NCT05096442 - Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Coronary De Novo Lesions N/A