An interventional study of ADVA ACE Everolimus Eluting Coronary Stent System in Coronary Artery Disease, De Novo Stenosis Lesion and Coronary Stent Implantation, sponsored by Advanced MedTech Solutions Pvt. Ltd.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Advanced MedTech Solutions Pvt. Ltd. · Not applicable, Interventional, and Treatment
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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.
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.
4,861 studies on the registry are indexed under Coronary Artery Disease; 892 are open to participants now.
This study's planned enrollment of 110 is below the median of 124 across 3,009 interventional studies indexed under Coronary Artery Disease.
Browse Coronary Artery Disease studies →Advanced MedTech Solutions Pvt. Ltd. is the lead sponsor of 2 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Device: ADVA ACE Everolimus Eluting Coronary Stent System
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.
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
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)
a composite of Cardiovascular (CV) death, TV-MI and CD-TVR, and individual components of composite end points
Time frame: 30, 180 and 360 days
Non-Target Vessel related Myocardial Infarction
Time frame: 30, 180, and 360 days
Stent thrombosis
Stent thrombosis as per 1. Academic Research Consortium \[ARC\] 2 Evidence definitions - Definite and probable. 2. As per latency - Acute (0-24 hours), Subacute (24 hours- 30 days) and late (30-365 days)
Time frame: 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
Time frame: 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.
Time frame: 0 hour, 24 hours, 3 days
Lesion success
Defined as achievement of \< 20% residual stenosis using any percutaneous method.
Time frame: 0 hour, 24 hours, 3 days
QCA Endpoints
Late Lumen Loss
Time frame: 0 and 180 days
QCA Endpoints
Angiographic binary restenosis
Time frame: 0 and 180 days
QCA Endpoints
In-stent and in-segment minimum lumen diameter (MLD)
Time frame: 0 and 180 days
QCA Endpoints
In-stent and in-segment % diameter stenosis (DS)
Time frame: 0 and 180 days
OCT Endpoints
Minimal Lumen Area (MLA)
Time frame: 0 and 180 days
OCT Endpoints
Late lumen loss (LLL)
Time frame: 0 and 180 days
OCT Endpoints
Percentage area stenosis
Time frame: 0 and 180 days
OCT Endpoints
Neointimal hyperplasia
Time frame: 0 and 180 days
OCT Endpoints
proportion of in stent and in segment binary restenosis
Time frame: 0 and 180 days
OCT Endpoints
Proportion of struts uncovered and malapposed
Time frame: 0 and 180 days
No study locations are listed for this record.
Plan to share: No
Start is estimated for Nov 2026; primary completion for Nov 2028, 24 months later.
Of 753 non-industry interventional studies with no phase under Coronary Artery Disease, half reached primary completion within 33 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 53. This study's planned 24 months is below that.
Counting every sponsor, half of 930 studies reached it within 30 months; a quarter within 15 and three quarters within 50.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Advanced MedTech Solutions Pvt. Ltd.