Coronary Artery DiseaseADVANCENCT07912541
ADVA ACE Coronary Stent System in Coronary Artery Disease Patients (ADVANCE)
A study testing ADVA ACE Everolimus 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, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population. 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?
- ADVA ACE Everolimus Eluting Coronary Stent System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to May 2029
- 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 participate by signing the informed consent form.
- Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per current ESC / AHA/ WCC or hospital's approved guidelines.
- Patient with coronary artery disease having de novo lesion in native coronary arteries with a visually estimated diameter stenosis ≥50 %.
- Patients with Reference vessel diameter of 2.25 to 4.5 mm.
- Patients with lesion length ≤36 mm.
Who cannot join
- Pregnant and/or lactating females.
- Patients under judicial protection, tutorship, curatorship, imprisonment etc (for Europe only).
- Patients requiring staged procedure.
- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30%.
- Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
- Current medical condition with a life expectancy of less than 12 months.
Show all 17Show fewer
- Diagnosis: Acute Myocardial Infarction within 72 hours of Planned Index procedure.
- Patient has current unstable arrhythmias.
- Patients previously treated with PCI or CABG for any coronary artery lesion revascularization.
- Patients with Chronic Total Occlusion or In-Stent Restenosis lesion.
- Patients with Ostial Lesions (within 5.0mm of vessel origin).
- Patients with Bifurcation lesions that include a side branch >2.0 mm diameter.
- Unprotected Left Main Coronary Artery lesion.
- Heavily calcified lesion and/or calcified lesion which cannot be successfully predilated in opinion of the treating cardiologist.
- Patients with Cardiogenic shock, systemic bleeding and coagulation disorders, intracranial bleeding, Renal insufficiency requiring dialysis, Acute or chronic renal dysfunction (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.
- Patients with platelet count <100.000 cells/mm3 or >700.000 cells/mm3 or a WBC<3.000 cells/mm3.
- Currently participating in another clinical trial.
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, Global, Multi-centre, Single-arm Clinical Study to Evaluate the Safety and Performance of ADVA ACE Everolimus elutiNg Coronary Stent System in Coronary Artery Disease in Indian & European Population (ADVANCE)
A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population.
To evaluate the performance of ADVA ACE Everolimus Eluting Stent, follow up indicated by MACE at 6 months.
Read more
Of the 110, 40 patients will be assigned to European population, and 70 patients will be assigned to Indian population. QCA is applicable to all Indian patients while OCT applicable for 10 Indian patients only at baseline and 6-months follow-up visit.
A QCA Analysis will be performed on all 70 patients in Indian population \& 10 Indian patients only.
Interval (Days) for patients visit at Day 0, Day 30±14, Day 180±14 and Day 360±14.
Read the detailed description
A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population. (ADVANCE)
A QCA Analysis will be performed on all 70 patients in Indian population \& OCT for only 10 Indian patients at baseline visit and at 6-month follow up visit.
Interval (Days) for patients visit at Day 0, Day 30±14, Day 180±14 and Day 360±14.
Sample size distribution:
Of the 110, 40 patients will be assigned to European population, and 70 patients will be assigned to Indian population.
Primary Objective:
To evaluate the performance of Adva ACE Everolimus Eluting Stent assessed by Major Adverse Cardiac Events (MACE) a composite of cardiovascular death, non-fatal Myocardial Infarction (MI) and Clinically driven Target Vessel Revascularization (CD-TVR) at 180 days.
Secondary Objectives:
To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30 and 360 days, clinically driven target lesion revascularization (CD-TLR), Target vessel failure (TVF) a composite of cardiovascular death, Target Vessel Myocardial Infarction (TV-MI) and Clinically driven Target Vessel Revascularization (CD-TVR), Stent thrombosis and individual components of composite endpoints at 30, 180 and 360 days.
To estimate device and procedure success of Adva ACE Everolimus Eluting stent on the device and procedure.
To estimate angiographic (QCA) and OCT parameters of performance of Adva ACE Everolimus eluting stent as defined by Late lumen loss and percentage diameter stenosis at 180 days (For India Only).
Exploratory objectives: None
Stent is approved for manufacturing and marketing in India.
- Being tested
- ADVA ACE Everolimus Eluting Coronary Stent System
- Keywords
- ADVA ACE Everolimus Eluting Coronary Stent System, Late Lumen Loss, QCA, OCT, percutaneous coronary intervention, Advanced Medtech Solutions
- 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.
ADVA ACE Everolimus Eluting Coronary Stent SystemDevice
ADVA ACE - Everolimus Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (coronary stent system) and a drug product (a formulation of Everolimus contained in a biodegradable polymer coating). is uniquely designed with a low polymer load, abluminal coating and bioabsorbable polymer matrix which may reduce the risk of thrombosis and the need for prolonged dual antiplatelet therapy.
| Study group | Role | What they receive |
|---|---|---|
| ADVA ACE Everolimus Eluting Coronary Stent System | Other | Not described Receives: Device: ADVA ACE Everolimus Eluting Coronary Stent System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major adverse cardiac events (MACE) - defined as composite of cardiovascular death, non-fatal myocardial infarction (MI), and clinically driven target vessel revascularization (CD-TVR)
Measured: 180 days
Secondary outcomes (8)
Incidence of Major Advance Cardiac Events 1. Cardiac Death 2. Non- fatal Myocardial Infarction 3. Clinically driven Target Vessel Revascularization
Measured: 30 and 360 days
Clinically driven target lesion revascularization (CD-TLR)
Measured: 30, 180 and 360 days
Target vessel failure (TVF)
a composite of Cardiovascular (CV) death, TV-MI and CD-TVR, and individual components of composite end points
Measured: 30, 180 and 360 days
Non-Target Vessel related Myocardial Infarction
Measured: 30, 180, and 360 days
Stent thrombosis
Stent thrombosis as per
- Academic Research Consortium [ARC] 2 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
Defined as achievement of a final residual stenosis of <20%, Successful deployment of stent with complete retrieval of delivery system without coronary dissection, device deformation \& visible mal apposition on fluoroscopy with stent boost
Measured: 0 hour, 24 hours, 3 days
Procedural Success
Defined as achievement of a final diameter stenosis of < 20%(site reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay.
Measured: 0 hour, 24 hours, 3 days
Lesion success
Defined as achievement of < 20% residual stenosis using any percutaneous method.
Measured: 0 hour, 24 hours, 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionNov 2028 (estimated)
- Study completionMay 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)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
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.
- Sponsor type
- University, hospital or other
- Collaborators
- Clicebo Solutions Private Limited
- Responsible party
- Sponsor
- Investigators
- Dr. Upendra Kaul, M.B.B.S., M.D, D.M Cardiology, Principal investigator, Batra Hospital & Medical Research Centre, New Delhi-110062
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07912541
- Sponsor's protocol ID
- AMS/PL/2026/001
- Acronym
- ADVANCE
- Status last verified
- Oct 2026
- First submitted
- 21 Oct 2026
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Medical Device Coordination Group (MDCG). MDCG 2020-10/1 Rev. 1: Guidance on Safety Reporting in Clinical Investigations of Medical Devices under Regulation (EU) 2017/745. European Commission.
European Parliament and Council of the European Union. Regulation (EU) 2017/745 of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union. 2017; L117:1-175.
Government of India, Ministry of Health and Family Welfare. Medical Devices Rules, 2017. Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), 31 January 2017. Available at: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Division/Medical-Device-Rules/
Chopra HK, Ramakrishnan S, Pancholia AK, Bansal M, editors. CSI Cardiology Update 2014. 1st ed. New Delhi: Jaypee Brothers Medical Publishers; 2015.
Coherent Market Insights. India Coronary Stents Market. Available at: https://www.coherentmarketinsights.com/market-insight/india-coronary-stents-market-3484. Accessed 11 May 2025.
Eurostat. Cardiovascular diseases statistics. European Commission. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php/Cardiovascular_diseases_statistics. Accessed 11 May 2025.
Aminian, Alireza, et al. "Trends in Percutaneous Coronary Intervention for In-Stent Restenosis in the United States." Journal of the American College of Cardiology, vol. 76, no. 10, 2020, pp. 1131-42
World Heart Federation. World Heart Report 2023: Confronting the World's Number One Killer. Heart Federation, 2023, https://world-heart-federation.org/wp-content/uploads/World-Heart-Report-2023.pdf
Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.
PubMed 34895950Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
PubMed 30165437Casanova-Sandoval J, Minana-Escriva G, Bosch-Peligero E, Munoz-Camacho JF, Fernandez-Rodriguez D, Rivera K, Fernandez-Cisnal A, Valcarcel-Paz D, Garcia-Guimaraes M. The ultrathin-strut everolimus-eluting stent in a real-world population: the Everythin multicenter registry. REC Interv Cardiol. 2025 Feb 24;7(1):23-28. doi: 10.24875/RECICE.M24000481. eCollection 2025 Jan-Mar.
PubMed 40417152Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.
PubMed 25855680Karmpaliotis D, Stoler R, Walsh S, El-Jack S, Potluri S, Moses J, Oldroyd K, Banning A, Webster M, Zaman A, Wu W, Ahmed M, Underwood P, Allocco D. Safety and efficacy of Everolimus-Eluting bioabsorbable Polymer-Coated stent in patients with long coronary lesions: The EVOLVE 48 study. Catheter Cardiovasc Interv. 2022 Feb;99(2):373-380. doi: 10.1002/ccd.29798. Epub 2021 May 29.
PubMed 34051049Jensen LO, Thayssen P, Christiansen EH, Maeng M, Ravkilde J, Hansen KN, Hansen HS, Krusell L, Kaltoft A, Tilsted HH, Berencsi K, Junker A, Lassen JF; SORT OUT IV Investigators. Safety and Efficacy of Everolimus- Versus Sirolimus-Eluting Stents: 5-Year Results From SORT OUT IV. J Am Coll Cardiol. 2016 Feb 23;67(7):751-62. doi: 10.1016/j.jacc.2015.11.051.
PubMed 26892409Patted SV. Safety and efficacy of Evermine50 Everolimus-eluting coronary stent system in patients with native coronary artery lesions: Three-year outcomes from a single-center. J Cardiovasc Thorac Res. 2025 Mar 18;17(1):58-65. doi: 10.34172/jcvtr.025.33123. eCollection 2025 Mar.
PubMed 40365519
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Global, Multi-centre, Single-arm Clinical Study to Evaluate the Safety and Performance of ADVA ACE Everolimus elutiNg Coronary Stent System in Coronary Artery Disease in Indian & European Population (ADVANCE)
- ClinicalTrials.gov ID
- NCT07912541
- Acronym / sponsor ID
- ADVANCE / AMS/PL/2026/001
- Keywords
- ADVA ACE Everolimus Eluting Coronary Stent System, Late Lumen Loss, QCA, OCT, percutaneous coronary intervention, Advanced Medtech Solutions
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Advanced MedTech Solutions Pvt. Ltd.University, hospital or other
- Collaborators
- Clicebo Solutions Private Limited
- Study start
- Nov 2026 (estimated)
- Primary completion
- Nov 2028 (estimated)
- Study completion
- May 2029 (estimated)
- First posted
- 3 Nov 2026 (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, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population.
To evaluate the performance of ADVA ACE Everolimus Eluting Stent, follow up indicated by MACE at 6 months.
Of the 110, 40 patients will be assigned to European population, and 70 patients will be assigned to Indian population. QCA is applicable to all Indian patients while OCT applicable for 10 Indian patients only at baseline and 6-months follow-up visit.
A QCA Analysis will be performed on all 70 patients in Indian population \& 10 Indian patients only.
Interval (Days) for patients visit at Day 0, Day 30±14, Day 180±14 and Day 360±14.
Detailed description
A prospective, global, multi-centre, single-arm clinical study to evaluate the Safety and Performance of ADVA ACE Everolimus eluting Coronary Stent System in Coronary Artery Disease in Indian \& European population. (ADVANCE)
A QCA Analysis will be performed on all 70 patients in Indian population \& OCT for only 10 Indian patients at baseline visit and at 6-month follow up visit.
Interval (Days) for patients visit at Day 0, Day 30±14, Day 180±14 and Day 360±14.
Sample size distribution:
Of the 110, 40 patients will be assigned to European population, and 70 patients will be assigned to Indian population.
Primary Objective:
To evaluate the performance of Adva ACE Everolimus Eluting Stent assessed by Major Adverse Cardiac Events (MACE) a composite of cardiovascular death, non-fatal Myocardial Infarction (MI) and Clinically driven Target Vessel Revascularization (CD-TVR) at 180 days.
Secondary Objectives:
To estimate patient safety and performance through incidence of Major Adverse Cardiac Events (MACE) at 30 and 360 days, clinically driven target lesion revascularization (CD-TLR), Target vessel failure (TVF) a composite of cardiovascular death, Target Vessel Myocardial Infarction (TV-MI) and Clinically driven Target Vessel Revascularization (CD-TVR), Stent thrombosis and individual components of composite endpoints at 30, 180 and 360 days.
To estimate device and procedure success of Adva ACE Everolimus Eluting stent on the device and procedure.
To estimate angiographic (QCA) and OCT parameters of performance of Adva ACE Everolimus eluting stent as defined by Late lumen loss and percentage diameter stenosis at 180 days (For India Only).
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 |
|---|---|---|
| ADVA ACE Everolimus Eluting Coronary Stent System | Other | Device: ADVA ACE Everolimus 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 participate by signing the informed consent form.
- Patient with coronary artery disease eligible for percutaneous coronary intervention (PCI) as per current ESC / AHA/ WCC or hospital's approved guidelines.
- Patient with coronary artery disease having de novo lesion in native coronary arteries with a visually estimated diameter stenosis ≥50 %.
Key exclusion criteria (17 listed)
- Pregnant and/or lactating females.
- Patients under judicial protection, tutorship, curatorship, imprisonment etc (for Europe only).
- Patients requiring staged procedure.
- Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) <30%.
- Patients with known hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, Everolimus or similar drugs, or any other analogue or derivative, cobalt, chromium, nickel, molybdenum or contrast media.
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 |
|---|---|---|
| ADVA ACE Everolimus Eluting Coronary Stent SystemADVA ACE - Everolimus Eluting Coronary Stent System is a device/drug combination product comprised of two regulated components: a device (coronary stent system) and a drug product (a formulation of Everolimus contained in a biodegradable polymer coating). is uniquely designed with a low polymer load, abluminal coating and bioabsorbable polymer matrix which may reduce the risk of thrombosis and the need for prolonged dual antiplatelet therapy. | Device | ADVA ACE Everolimus Eluting Coronary Stent System |
Primary outcome
Major adverse cardiac events (MACE) - defined as composite of cardiovascular death, non-fatal myocardial infarction (MI), and clinically driven target vessel revascularization (CD-TVR)
Time frame: 180 days
8 secondary outcomes
Incidence of Major Advance Cardiac Events 1. Cardiac Death 2. Non- fatal Myocardial Infarction 3. Clinically driven Target Vessel Revascularization
Time frame: 30 and 360 days
Clinically driven target lesion revascularization (CD-TLR)
Time frame: 30, 180 and 360 days
Target vessel failure (TVF)
Time frame: 30, 180 and 360 days
Non-Target Vessel related Myocardial Infarction
Time frame: 30, 180, 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: 0 hour, 24 hours, 3 days
Lesion success
Time frame: 0 hour, 24 hours, 3 days
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 3 Nov 2026.
- BackgroundMedical Device Coordination Group (MDCG). MDCG 2020-10/1 Rev. 1: Guidance on Safety Reporting in Clinical Investigations of Medical Devices under Regulation (EU) 2017/745. European Commission.
- BackgroundEuropean Parliament and Council of the European Union. Regulation (EU) 2017/745 of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009, and repealing Council Directives 90/385/EEC and 93/42/EEC. Official Journal of the European Union. 2017; L117:1-175.
- BackgroundGovernment of India, Ministry of Health and Family Welfare. Medical Devices Rules, 2017. Gazette of India, Extraordinary, Part II, Section 3, Sub-section (i), 31 January 2017. Available at: https://cdsco.gov.in/opencms/opencms/en/Medical-Device-Division/Medical-Device-Rules/
- BackgroundChopra HK, Ramakrishnan S, Pancholia AK, Bansal M, editors. CSI Cardiology Update 2014. 1st ed. New Delhi: Jaypee Brothers Medical Publishers; 2015.
- BackgroundCoherent Market Insights. India Coronary Stents Market. Available at: https://www.coherentmarketinsights.com/market-insight/india-coronary-stents-market-3484. Accessed 11 May 2025.
- BackgroundEurostat. Cardiovascular diseases statistics. European Commission. Available at: https://ec.europa.eu/eurostat/statistics-explained/index.php/Cardiovascular_diseases_statistics. Accessed 11 May 2025.
- BackgroundAminian, Alireza, et al. "Trends in Percutaneous Coronary Intervention for In-Stent Restenosis in the United States." Journal of the American College of Cardiology, vol. 76, no. 10, 2020, pp. 1131-42
- BackgroundWorld Heart Federation. World Heart Report 2023: Confronting the World's Number One Killer. Heart Federation, 2023, https://world-heart-federation.org/wp-content/uploads/World-Heart-Report-2023.pdf
- Results publication: PubMed 34895950Writing Committee Members; Lawton JS, Tamis-Holland JE, Bangalore S, Bates ER, Beckie TM, Bischoff JM, Bittl JA, Cohen MG, DiMaio JM, Don CW, Fremes SE, Gaudino MF, Goldberger ZD, Grant MC, Jaswal JB, Kurlansky PA, Mehran R, Metkus TS Jr, Nnacheta LC, Rao SV, Sellke FW, Sharma G, Yong CM, Zwischenberger BA. 2021 ACC/AHA/SCAI Guideline for Coronary Artery Revascularization: A Report of the American College of Cardiology/American Heart Association Joint Committee on Clinical Practice Guidelines. J Am Coll Cardiol. 2022 Jan 18;79(2):e21-e129. doi: 10.1016/j.jacc.2021.09.006. Epub 2021 Dec 9.
- Results publication: PubMed 30165437Neumann FJ, Sousa-Uva M, Ahlsson A, Alfonso F, Banning AP, Benedetto U, Byrne RA, Collet JP, Falk V, Head SJ, Juni P, Kastrati A, Koller A, Kristensen SD, Niebauer J, Richter DJ, Seferovic PM, Sibbing D, Stefanini GG, Windecker S, Yadav R, Zembala MO; ESC Scientific Document Group. 2018 ESC/EACTS Guidelines on myocardial revascularization. Eur Heart J. 2019 Jan 7;40(2):87-165. doi: 10.1093/eurheartj/ehy394. No abstract available.
- Results publication: PubMed 40417152Casanova-Sandoval J, Minana-Escriva G, Bosch-Peligero E, Munoz-Camacho JF, Fernandez-Rodriguez D, Rivera K, Fernandez-Cisnal A, Valcarcel-Paz D, Garcia-Guimaraes M. The ultrathin-strut everolimus-eluting stent in a real-world population: the Everythin multicenter registry. REC Interv Cardiol. 2025 Feb 24;7(1):23-28. doi: 10.24875/RECICE.M24000481. eCollection 2025 Jan-Mar.
- Results publication: PubMed 25855680Kereiakes DJ, Meredith IT, Windecker S, Lee Jobe R, Mehta SR, Sarembock IJ, Feldman RL, Stein B, Dubois C, Grady T, Saito S, Kimura T, Christen T, Allocco DJ, Dawkins KD. Efficacy and safety of a novel bioabsorbable polymer-coated, everolimus-eluting coronary stent: the EVOLVE II Randomized Trial. Circ Cardiovasc Interv. 2015 Apr;8(4):e002372. doi: 10.1161/CIRCINTERVENTIONS.114.002372.
- 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. Upendra Kaul, M.B.B.S., M.D, D.M Cardiology principal investigator
Batra Hospital & Medical Research Centre, New Delhi-110062
Questions about this trial
What is this clinical trial studying?
A study testing ADVA ACE Everolimus 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 17 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 3 Nov 2026. 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 Sudipt Chakraborty (+91 9211465538, schakraborty@amsltd.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major adverse cardiac events (MACE) - defined as composite of cardiovascular death, non-fatal myocardial infarction (MI), and clinically driven target vessel revascularization (CD-TVR) (time frame: 180 days). 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 NCT07912541, which also lists 20 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 3 Nov 2026.