Advapro Coronary Stent System in Coronary Artery Diseased Patients.

Coronary Artery Disease Clinical Trial

— RESTORE  

Official title:

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)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06300268
• Other study ID #: CSPL/PL/2023/004
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 2026

Study information

• Verified date: February 2024
• Source: Advanced MedTech Solutions Pvt. Ltd.
• Contact: Dr Jayesh Jani
• Phone: 8130009876
• Email: jjani[@]amsltd.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Stent Implantation

Intervention

Device:
• AdvaPro Sirolimus Eluting Coronary Stent System
Cardiac Stent

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Advanced MedTech Solutions Pvt. Ltd.

References & Publications (27)

Abizaid A, Costa JR Jr. New drug-eluting stents: an overview on biodegradable and polymer-free next-generation stent systems. Circ Cardiovasc Interv. 2010 Aug;3(4):384-93. doi: 10.1161/CIRCINTERVENTIONS.109.891192. No abstract available. — View Citation

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 e — View Citation

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. — View Citation

Dani S, Costa RA, Joshi H, Shah J, Pandya R, Virmani R, Sheiban I, Bhatt S, Abizaid A. First-in-human evaluation of the novel BioMime sirolimus-eluting coronary stent with bioabsorbable polymer for the treatment of single de novo lesions located in native — View Citation

Fajadet J, Wijns W, Laarman GJ, Kuck KH, Ormiston J, Munzel T, Popma JJ, Fitzgerald PJ, Bonan R, Kuntz RE; ENDEAVOR II Investigators. Randomized, double-blind, multicenter study of the Endeavor zotarolimus-eluting phosphorylcholine-encapsulated stent for — View Citation

Goy JJ, Stauffer JC, Siegenthaler M, Benoit A, Seydoux C. A prospective randomized comparison between paclitaxel and sirolimus stents in the real world of interventional cardiology: the TAXi trial. J Am Coll Cardiol. 2005 Jan 18;45(2):308-11. doi: 10.1016 — View Citation

Iakovou I, Schmidt T, Bonizzoni E, Ge L, Sangiorgi GM, Stankovic G, Airoldi F, Chieffo A, Montorfano M, Carlino M, Michev I, Corvaja N, Briguori C, Gerckens U, Grube E, Colombo A. Incidence, predictors, and outcome of thrombosis after successful implantat — View Citation

Kandzari DE, Leon MB. Overview of pharmacology and clinical trials program with the zotarolimus-eluting endeavor stent. J Interv Cardiol. 2006 Oct;19(5):405-13. doi: 10.1111/j.1540-8183.2006.00184.x. — View Citation

Lemos PA, Moulin B, Perin MA, Oliveira LA, Arruda JA, Lima VC, Lima AA, Caramori PR, Medeiros CR, Barbosa MR, Brito FS Jr, Ribeiro EE, Martinez EE; PAINT trial investigators. Randomized evaluation of two drug-eluting stents with identical metallic platfor — View Citation

Levine GN, Bates ER, Blankenship JC, Bailey SR, Bittl JA, Cercek B, Chambers CE, Ellis SG, Guyton RA, Hollenberg SM, Khot UN, Lange RA, Mauri L, Mehran R, Moussa ID, Mukherjee D, Nallamothu BK, Ting HH; American College of Cardiology Foundation; American — View Citation

Maisel WH. Unanswered questions--drug-eluting stents and the risk of late thrombosis. N Engl J Med. 2007 Mar 8;356(10):981-4. doi: 10.1056/NEJMp068305. Epub 2007 Feb 12. No abstract available. — View Citation

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. — View Citation

Mauri L, Hsieh WH, Massaro JM, Ho KK, D'Agostino R, Cutlip DE. Stent thrombosis in randomized clinical trials of drug-eluting stents. N Engl J Med. 2007 Mar 8;356(10):1020-9. doi: 10.1056/NEJMoa067731. Epub 2007 Feb 12. — View Citation

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. Lanc — View Citation

Mehilli J, Dibra A, Kastrati A, Pache J, Dirschinger J, Schomig A; Intracoronary Drug-Eluting Stenting to Abrogate Restenosis in Small Arteries (ISAR-SMART 3) Study Investigators. Randomized trial of paclitaxel- and sirolimus-eluting stents in small coron — View Citation

Morice MC, Colombo A, Meier B, Serruys P, Tamburino C, Guagliumi G, Sousa E, Stoll HP; REALITY Trial Investigators. Sirolimus- vs paclitaxel-eluting stents in de novo coronary artery lesions: the REALITY trial: a randomized controlled trial. JAMA. 2006 Fe — View Citation

Ong AT, McFadden EP, Regar E, de Jaegere PP, van Domburg RT, Serruys PW. Late angiographic stent thrombosis (LAST) events with drug-eluting stents. J Am Coll Cardiol. 2005 Jun 21;45(12):2088-92. doi: 10.1016/j.jacc.2005.02.086. — View Citation

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. — View Citation

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 — View Citation

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. — View Citation

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Sousa JE, Costa MA, Abizaid AC, Rensing BJ, Abizaid AS, Tanajura LF, Kozuma K, Van Langenhove G, Sousa AG, Falotico R, Jaeger J, Popma JJ, Serruys PW. Sustained suppression of neointimal proliferation by sirolimus-eluting stents: one-year angiographic and — View Citation

Stefanini GG, Byrne RA, Serruys PW, de Waha A, Meier B, Massberg S, Juni P, Schomig A, Windecker S, Kastrati A. Biodegradable polymer drug-eluting stents reduce the risk of stent thrombosis at 4 years in patients undergoing percutaneous coronary intervent — View Citation

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 1 — View Citation

Williams DO, Abbott JD, Kip KE; DEScover Investigators. Outcomes of 6906 patients undergoing percutaneous coronary intervention in the era of drug-eluting stents: report of the DEScover Registry. Circulation. 2006 Nov 14;114(20):2154-62. doi: 10.1161/CIRC — View Citation

Windecker S, Remondino A, Eberli FR, Juni P, Raber L, Wenaweser P, Togni M, Billinger M, Tuller D, Seiler C, Roffi M, Corti R, Sutsch G, Maier W, Luscher T, Hess OM, Egger M, Meier B. Sirolimus-eluting and paclitaxel-eluting stents for coronary revascular — View Citation

Windecker S, Serruys PW, Wandel S, Buszman P, Trznadel S, Linke A, Lenk K, Ischinger T, Klauss V, Eberli F, Corti R, Wijns W, Morice MC, di Mario C, Davies S, van Geuns RJ, Eerdmans P, van Es GA, Meier B, Juni P. Biolimus-eluting stent with biodegradable — View Citation

* Note: There are 27 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	For QCA Group	• Late Lumen Loss	270 Days
Other	For QCA Group	• Angiographic binary restenosis	270 Days
Other	For QCA Group	• In-stent and in-segment minimum lumen diameter (MLD) and % diameter stenosis (DS)	270 Days
Primary	Composite Endpoint	MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)	1 Year
Secondary	Incidence of DOCE	Cardiovascular Death; Myocardial infarction in the territory of Target vessel; Clinically driven target lesion revascularization	30 Days, 180 Days, 270 Days and 360 days
Secondary	Incidence of POCE	All cause death; Any Stroke; Any myocardial infarction; Any revascularization	30 Days, 180 Days, 270 Days and 360 days
Secondary	Incidence of MACE	Cardiovascular Death; Non-fatal MI; Target Vessel Revascularization	30 Days, 180 Days and 360 days
Secondary	Target vessel failure (TVF)	Target vessel failure (TVF)	30 Days, 180 Days, 270 Days and 360 days
Secondary	Non-Target Vessel related Myocardial Infarction	Non-Target Vessel related Myocardial Infarction	30 Days, 180 Days, 270 Days and 360 days
Secondary	Stent thrombosis	Stent thrombosis as per; Academic Research Consortium [ARC] Evidence definitions - Definite and probable; As per latency - Acute (0-24 hours), Subacute (24 hours-30 days) and late (30-365 days)	0-24 hours, 24 hours-30 days and late 30-365 days
Secondary	Device success	Residual coronary stenosis less than 20%; Normal coronary flow and absence of coronary dissections > C; Procedural and absence of PCI complications including periprocedural MI, coronary perforation, urgent CABG or death or revascularization within 3 days of Index procedure	0 hour, 24 hours, 3 days
Secondary	Procedural Success	Residual Stenosis less than 20%; Successful reperfusion of Target vessel region with TIMI Flow = 2	24 Hours
Secondary	Acute Device Success	Acute Device Success as defined by Residual Stenosis = 20%	24 Hours