ट्रायल रडार AI | ||
|---|---|---|
क्लिनिकल ट्रायल NCT05423379 (SPIRIT XLV PAS) के लिए कोरोनरी धमनी रोग वर्तमान में सक्रिय, भर्ती नहीं है। सभी विवरणों के लिए क्लिनिकल ट्रायल रडार कार्ड दृश्य और AI खोज उपकरण देखें, या यहाँ कुछ भी पूछें। | ||
एक परीक्षण फ़िल्टर मानदंडों से मेल खाता है
कार्ड दृश्य
खोज पर वापस जाएँ
एबॅटXIENCE Skypoint Large Vessel Post Approval Study (SPIRIT XLV PAS)
चिकित्सा परीक्षण का विवरण मुख्य रूप से अंग्रेजी में उपलब्ध है। हालाँकि, ट्रायल रडार AI मदद कर सकता है! बस 'परीक्षण समझाएं' पर क्लिक करें और अपनी चुनी हुई भाषा में परीक्षण की जानकारी देखें और चर्चा करें।
क्लिनिकल परीक्षण NCT05423379 (SPIRIT XLV PAS) एक प्रेक्षणीय चिकित्सकीय अध्ययन है जो कोरोनरी धमनी रोग से जुड़ा हुआ है। परीक्षण वर्तमान में सक्रिय, भर्ती नहीं चल रहा है। इसकी शुरुआत 14 सितंबर 2022 को हुई थी, और इसमें कुल 102 प्रतिभागियों के नामांकन की योजना है। एबॅट इस परीक्षण का नेतृत्व कर रहे हैं और इसके 30 अगस्त 2027 तक पूरा होने की उम्मीद है। ClinicalTrials.gov वेबसाइट पर यह जानकारी 8 जनवरी 2025 को अंतिम बार अपडेट की गई थी।
संक्षिप्त सारांश
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.
आधिकारिक शीर्षक
XIENCE Skypoint Large Vessel Post Approval Study
चिकित्सीय स्थितियाँ
कोरोनरी धमनी रोगअन्य अध्ययन आईडी
- SPIRIT XLV PAS
- ABT -CIP 10445
NCT नंबर
अध्ययन प्रारंभ तिथि (वास्तविक)
2022-09-14
अंतिम अद्यतन प्रकाशित
2025-01-08
अध्ययन की समाप्ति तिथि (अनुमानित)
2027-08-30
नामांकन (अनुमानित)
102
अध्ययन प्रकार
प्रेक्षणीय
स्थिति
सक्रिय, भर्ती नहीं
प्रमुख शब्द
ABT -CIP 10445
Coronary artery disease
XIENCE
Large Vessel
Skypoint
Coronary artery disease
XIENCE
Large Vessel
Skypoint
समूह/हस्तक्षेप
| प्रतिभागी समूह/हाथ | हस्तक्षेप/इलाज |
|---|---|
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. |
प्राथमिक परिणाम माप
| परिणाम माप | माप विवरण | समय सीमा |
|---|---|---|
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 |
पात्रता मानदंड
अध्ययन के लिए पात्र आयु
वयस्क, वृद्ध वयस्क
अध्ययन के लिए न्यूनतम आयु
18 Years
अध्ययन के लिए पात्र लिंग
सभी
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.
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 Exclusion Criteria:
Patients who require three vessel treatment.
If left main coronary artery (LMCA) is the intended target vessel, patients who have unprotected left main disease with the SYNTAX Score ≥ 23
- 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
- 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.
कोई संपर्क डेटा नहीं।
18 3 देशों में अध्ययन स्थल
Arkansas
Arkansas Heart Hospital, Little Rock, Arkansas, 72211, United States
Florida
Memorial Hospital Jacksonville, Jacksonville, Florida, 32216, United States
Tallahassee Research Institute, Tallahassee, Florida, 32308, United States
Kansas
Via Christi Regional Medical Center - St. Francis Campus, Wichita, Kansas, 67226, United States
Nebraska
Bryan Heart, Lincoln, Nebraska, 68506, United States
New York
Lenox Hill Hospital, New York, New York, 10075, United States
Pennsylvania
Pinnacle Health System, Wormleysburg, Pennsylvania, 17043, United States
South Carolina
Anmed Health, Anderson, South Carolina, 29621, United States
Greenville Health System, Greenville, South Carolina, 29605-5601, United States
Texas
Hendrick Medical Center, Abilene, Texas, 79601, United States
Austin Heart, Austin, Texas, 78756, United States
The Heart Hospital Baylor Plano, Plano, Texas, 75074, United States
Shannon Clinic, San Angelo, Texas, 76903, United States
Midi-Pyrenees
Clinique Pasteur Toulouse, Toulouse, Midi-Pyrenees, 31300, France
Rhone
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