Coronary Artery DiseaseRESTORENCT06300268
Advapro Coronary Stent System in Coronary Artery Diseased Patients.
A study testing AdvaPro Sirolimus Eluting Coronary Stent System in people with Coronary Artery Disease and De Novo Stenosis Lesion, run by Advanced MedTech Solutions Pvt. Ltd..
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Artery Disease, De Novo Stenosis Lesion, Coronary Stent Implantation
- What is being tested?
- AdvaPro Sirolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Jun 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 15Show fewer
- 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
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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)
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.
Read the detailed 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.
- Being tested
- AdvaPro Sirolimus Eluting Coronary Stent System
- Keywords
- AdvaPro Sirolimus Eluting Coronary Stent System, Late lumen loss, Advanced Medtech Solutions, QCA, PTCA
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AdvaPro Sirolimus Eluting Coronary Stent SystemDevice
Cardiac Stent
| Study group | Role | What they receive |
|---|---|---|
| Interventional | Other | AdvaPro Sirolimus Eluting Coronary Stent System Receives: Device: AdvaPro Sirolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
Measured: 1 Year
Secondary outcomes (9)
Incidence of DOCE
- Cardiovascular Death
- Myocardial infarction in the territory of Target vessel
- Clinically driven target lesion revascularization
Measured: 30 Days, 180 Days, 270 Days and 360 days
Incidence of POCE
- All cause death
- Any Stroke
- Any myocardial infarction
- Any revascularization
Measured: 30 Days, 180 Days, 270 Days and 360 days
Incidence of MACE
- Cardiovascular Death
- Non-fatal MI
- Target Vessel Revascularization
Measured: 30 Days, 180 Days and 360 days
Target vessel failure (TVF)
Target vessel failure (TVF)
Measured: 30 Days, 180 Days, 270 Days and 360 days
Non-Target Vessel related Myocardial Infarction
Non-Target Vessel related Myocardial Infarction
Measured: 30 Days, 180 Days, 270 Days and 360 days
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)
Measured: 0-24 hours, 24 hours-30 days and late 30-365 days
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
Measured: 0 hour, 24 hours, 3 days
Procedural Success
- Residual Stenosis less than 20%
- Successful reperfusion of Target vessel region with TIMI Flow ≥ 2
Measured: 24 Hours
Acute Device Success
Acute Device Success as defined by Residual Stenosis ≤ 20%
Measured: 24 Hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study startJun 2024 (estimated)
- Primary completionJun 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Pilot Study (Open Label)
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr Philippe Garot, Principal investigator, Hôpital Privé Jacques Cartier, Massy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300268
- Sponsor's protocol ID
- CSPL/PL/2023/004
- Acronym
- RESTORE
- Status last verified
- Feb 2024
- First submitted
- 21 Feb 2024
- Last updated
- 8 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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-e1214. doi: 10.4244/EIJ-D-18-00762.
PubMed 30222120Mathers 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.
PubMed 17132052Virmani 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.
PubMed 14744976McFadden 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.
PubMed 15500897Palmerini 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.
PubMed 24036025Bavry 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.
PubMed 17145250Scott 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.
PubMed 16733073Price 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.
PubMed 16487858Williams 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/CIRCULATIONAHA.106.667915. Epub 2006 Oct 23.
PubMed 17060386Windecker 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 polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
PubMed 18765162Morice 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 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.
PubMed 16493102Windecker 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 revascularization. N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.
PubMed 16105989Lemos 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 platform and biodegradable polymer but different agents (paclitaxel or sirolimus) compared against bare stents: 1-year results of the PAINT trial. Catheter Cardiovasc Interv. 2009 Nov 1;74(5):665-73. doi: 10.1002/ccd.22166.
PubMed 19670303Goy 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/j.jacc.2004.10.062.
PubMed 15653032Mehilli 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 coronary vessels. Eur Heart J. 2006 Feb;27(3):260-6. doi: 10.1093/eurheartj/ehi721. Epub 2006 Jan 9.
PubMed 16401670
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT06300268
- Acronym / sponsor ID
- RESTORE / CSPL/PL/2023/004
- Keywords
- AdvaPro Sirolimus Eluting Coronary Stent System, Late lumen loss, Advanced Medtech Solutions, QCA, PTCA
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.University, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Pilot Study (Open Label)
| Arm | Type | Receives |
|---|---|---|
| Interventional | Other | Device: AdvaPro Sirolimus Eluting Coronary Stent SystemAdvaPro Sirolimus Eluting Coronary Stent System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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%
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AdvaPro Sirolimus Eluting Coronary Stent SystemCardiac Stent | Device | Interventional |
Primary outcome
Composite Endpoint
Time frame: 1 Year
MACE (Hierarchical incidence of Cardiovascular Death, Myocardial infarction or Target Vessel Revascularization)
9 secondary outcomes
Incidence of DOCE
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Incidence of POCE
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Incidence of MACE
Time frame: 30 Days, 180 Days and 360 days
Target vessel failure (TVF)
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Non-Target Vessel related Myocardial Infarction
Time frame: 30 Days, 180 Days, 270 Days and 360 days
Stent thrombosis
Time frame: 0-24 hours, 24 hours-30 days and late 30-365 days
Device success
Time frame: 0 hour, 24 hours, 3 days
Procedural Success
Time frame: 24 Hours
Acute Device Success
Time frame: 24 Hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2024.
- Results publication: PubMed 30222120Abizaid 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-e1214. doi: 10.4244/EIJ-D-18-00762.
- Results publication: PubMed 17132052Mathers 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.
- Results publication: PubMed 14744976Virmani 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.
- Results publication: PubMed 15500897McFadden 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.
- Results publication: PubMed 24036025Palmerini 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.
- Results publication: PubMed 17145250Bavry 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.
- Results publication: PubMed 16733073Scott 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.
- Results publication: PubMed 16487858Price 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.
- Results publication: PubMed 17060386Williams 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/CIRCULATIONAHA.106.667915. Epub 2006 Oct 23.
- Results publication: PubMed 18765162Windecker 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 polymer versus sirolimus-eluting stent with durable polymer for coronary revascularisation (LEADERS): a randomised non-inferiority trial. Lancet. 2008 Sep 27;372(9644):1163-73. doi: 10.1016/S0140-6736(08)61244-1. Epub 2008 Aug 31.
- Results publication: PubMed 16493102Morice 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 Feb 22;295(8):895-904. doi: 10.1001/jama.295.8.895.
- Results publication: PubMed 16105989Windecker 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 revascularization. N Engl J Med. 2005 Aug 18;353(7):653-62. doi: 10.1056/NEJMoa051175. Epub 2005 Aug 16.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr Philippe Garot principal investigator
Hôpital Privé Jacques Cartier, Massy
Questions about this trial
What is this clinical trial studying?
A study testing AdvaPro Sirolimus Eluting Coronary Stent System in people with Coronary Artery Disease and De Novo Stenosis Lesion, run by Advanced MedTech Solutions Pvt. Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Jayesh Jani (8130009876, jjani@amsltd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Endpoint (time frame: 1 Year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06300268, which also lists 27 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2024.