Advapro Coronary Stent System in Coronary Artery Diseased Patients.

Официальное название

A Prospective, MulticentRe, Pilot Study to Evaluate the Safety and Performance of The AdvaPro Sirolimus Eluting CorOnary Stent System in Coronary ARtery Stenosis in Indian and European Population(RESTORE)

Обзор

A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population. To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months. Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population. QCA is applicable for only in sub-strategy participants at baseline and 9 month follow-up visit. A QCA Analysis will be performed on minimum 48 patients in Indian population only. Interval(Days) for patients visit at Day 0, Day 30±6, Day 180±8, Day 270±10 and Day 360±14.

Подробное описание

A Prospective, Multicentre, Pilot Study to Evaluate the Safety and Performance of the AdvaPro Sirolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian and European Population(RESTORE).

A QCA Analysis will be performed on minimum 48 patients in Indian population only at baseline visit and 9 month follow-up.

Interval(Days) for patients visit at Day 0, Day 30±7, Day 180±8, Day 270±10 and Day 360±14.

Sample size distribution:

Of the 120, 40 patients will be assigned to European population and 80 patients will be assigned to Indian population.

Primary Objective:

To evaluate the performance of AdvaPro Sirolimus Eluting Stent follow up indicated by MACE at 9 months.

Secondary Objectives:

To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30, 180, 360 days and device oriented composite end point (DOCE), patient oriented composite end point (POCE) Stent Thrombosis, Target vessel failure (TVF), Target Vessel related Myocardial Infarction (TV-MI), and individual components of composite end points at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent.

To estimate device and procedure success at 30, 180, 270 and 360 days after use of AdvaPro Sirolimus Eluting Stent.

To Estimate Definitive parameters of performance of AdvaPro Sirolimus Eluting Stent as defined by Late Lumen Loss and Diameter Stenosis percentage at 270 days of AdvaPro Sirolimus Eluting Stent.

Exploratory objectives: None

Stent is approved for manufacturing and marketing in India.

Вмешательства

• Устройство AdvaPro Sirolimus Eluting Coronary Stent System
  Cardiac Stent

Первичные конечные точки

• Composite Endpoint [Срок оценки: 1 Year]

Вторичные конечные точки (9)

• Incidence of DOCE [Срок оценки: 30 Days, 180 Days, 270 Days and 360 days]
• Incidence of POCE [Срок оценки: 30 Days, 180 Days, 270 Days and 360 days]
• Incidence of MACE [Срок оценки: 30 Days, 180 Days and 360 days]
• Target vessel failure (TVF) [Срок оценки: 30 Days, 180 Days, 270 Days and 360 days]
• Non-Target Vessel related Myocardial Infarction [Срок оценки: 30 Days, 180 Days, 270 Days and 360 days]
• Stent thrombosis [Срок оценки: 0-24 hours, 24 hours-30 days and late 30-365 days]
• Device success [Срок оценки: 0 hour, 24 hours, 3 days]
• Procedural Success [Срок оценки: 24 Hours]
• Acute Device Success [Срок оценки: 24 Hours]

Критерии участия

Критерии включения

• Age >18 years
• Gender : All (Males, Females, Transgenders, Non-binary)
• ICF : Patient or legally authorized representative (LAR) agrees to participation by signing the informed consent form.
• Condition - Clinical : Patient with coronary artery disease Eligible for percutaneous coronary intervention (PCI)
• Condition - Angiographic : Patient with coronary artery disease having one or more de novo stenosis lesion in two native coronary artery with a visually estimated diameter stenosis ≥70%
• Condition - Angiographic : Patients with Reference vessel diameter of 2.5 \~ 3.50 mm
• Condition - Angiographic : Patients with lesion length ≤ 36 mm

Критерии исключения

• Ethical : Pregnant and lactating females
• Patients requiring staged procedure
• Condition : Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30%
• Condition : Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Sirolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media
• Condition : Current medical condition with a life expectancy of less than 12 months
• Condition : Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure
• Condition : Patient has current unstable arrhythmias
• Procedural : Patients previously treated with PCI or CABG for any coronary artery lesion revascularization
• Procedural : Patients with Chronic Total Occlusion in two or more vessels
• Procedural : Patients with Ostial lesions (within 5.0mm of vessel origin).
• Procedural : Patients with Bifurcation lesions that include a side branch >2.0 mm diameter
• Procedural : Unprotected Left Main Coronary Artery lesion
• Condition : Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist
• Condition : Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal function (serum creatinine >2.0mg/dl or 150 µmol/L), peripheral vascular diseases, cancer, etc. and patients who are planning to undergo surgery within 1 year of the index procedure
• Condition : Patients with platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC <3.000 cells/mm3

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• Abizaid A, Kedev S, Kedhi E, Talwar S, Erglis A, Hlinomaz O, Masotti M, Fath-Ordoubadi F, Lemos PA, Milewski K, Botelho R, Costa R, Bangalore S. Randomised comparison of a biodegradable polymer ultra-thin sirolimus-eluting stent versus a durable polymer everolimus-eluting stent in patients with de novo native coronary artery lesions: the meriT-V trial. EuroIntervention. 2018 Dec 7;14(11):e1207-e12 PMID 30222120
• Mathers CD, Loncar D. Projections of global mortality and burden of disease from 2002 to 2030. PLoS Med. 2006 Nov;3(11):e442. doi: 10.1371/journal.pmed.0030442. PMID 17132052
• Virmani R, Guagliumi G, Farb A, Musumeci G, Grieco N, Motta T, Mihalcsik L, Tespili M, Valsecchi O, Kolodgie FD. Localized hypersensitivity and late coronary thrombosis secondary to a sirolimus-eluting stent: should we be cautious? Circulation. 2004 Feb 17;109(6):701-5. doi: 10.1161/01.CIR.0000116202.41966.D4. Epub 2004 Jan 26. PMID 14744976
• McFadden EP, Stabile E, Regar E, Cheneau E, Ong AT, Kinnaird T, Suddath WO, Weissman NJ, Torguson R, Kent KM, Pichard AD, Satler LF, Waksman R, Serruys PW. Late thrombosis in drug-eluting coronary stents after discontinuation of antiplatelet therapy. Lancet. 2004 Oct 23-29;364(9444):1519-21. doi: 10.1016/S0140-6736(04)17275-9. PMID 15500897
• Palmerini T, Biondi-Zoccai G, Della Riva D, Mariani A, Genereux P, Branzi A, Stone GW. Stent thrombosis with drug-eluting stents: is the paradigm shifting? J Am Coll Cardiol. 2013 Nov 19;62(21):1915-1921. doi: 10.1016/j.jacc.2013.08.725. Epub 2013 Sep 11. PMID 24036025
• Bavry AA, Kumbhani DJ, Helton TJ, Borek PP, Mood GR, Bhatt DL. Late thrombosis of drug-eluting stents: a meta-analysis of randomized clinical trials. Am J Med. 2006 Dec;119(12):1056-61. doi: 10.1016/j.amjmed.2006.01.023. PMID 17145250
• Scott NA. Restenosis following implantation of bare metal coronary stents: pathophysiology and pathways involved in the vascular response to injury. Adv Drug Deliv Rev. 2006 Jun 3;58(3):358-76. doi: 10.1016/j.addr.2006.01.015. Epub 2006 Mar 6. PMID 16733073
• Price MJ, Cristea E, Sawhney N, Kao JA, Moses JW, Leon MB, Costa RA, Lansky AJ, Teirstein PS. Serial angiographic follow-up of sirolimus-eluting stents for unprotected left main coronary artery revascularization. J Am Coll Cardiol. 2006 Feb 21;47(4):871-7. doi: 10.1016/j.jacc.2005.12.015. Epub 2006 Jan 6. PMID 16487858

Идентификаторы

NCT: NCT06300268 · CSPL/PL/2023/004

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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