AzTrials
AzTrials

Coronary Artery DiseasePACIFIERNCT07098195

To Evaluate the Performance and Safety of RisoR Crest Everolimus Eluting Coronary Stent System

A study testing Coronary Stent in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Poly Medicure Limited.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy. Read more about this study

Who is it for?
Ages 18 to 99 years
What is being tested?
Coronary Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
2,000 participants
Where
No sites listed yet
Study dates
18 Aug 2025to 17 Jan 2028
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 to 99 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age more than 18 years
  • All Genders (Males, Females, Transgenders, Non binary)
  • 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 regional or hospital's standard practices guidelines for PCI (For Europe, as per ESC guidelines)
  • Patient with coronary artery disease having one or more de novo or in - stent stenosis lesions in native coronary artery with a visually estimated diameter stenosis ≥70%.
  • Patients with Reference vessel diameter of 2.0 to 4.5 mm
  • Patients with lesion length less than 48 mm

Who cannot join

  • Pregnant and lactating females
  • Candidates for emergency bypass Surgery
  • Patients corresponding to the criteria of a vulnerable population (Vulnerable subjects, including patients who are unable to fully understand all aspects of the investigation, patients who could be manipulated or unduly influenced, patients lacking capacity in the informed consent procedure and patients with dementia and cognitive impairment, patients under social security, imprisonment etc.)
  • Known congestive heart failure (NYHA IV) or left ventricular ejection fraction (LVEF) less than 30 Percent
  • 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 11Show fewer
  • Patient who have current unstable arrhythmias
  • Patient previously undergone CABG.
  • Left Main Coronary Artery lesion
  • 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 360 days of the index procedure
  • 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.

Dinesh Rajendra Patil contact

+91-8149037128

dinesh.patil@polymedicure.com

Priyadarshini Arambam contact

+91-9910990347

regulatory@clicebo.com

About this study

Official title: An OPen-label, Multicentre, Single Arm, Clinical InvestigatIon to Evaluate PerFormance and Safety of RIsoR Crest EveRolimus Eluting Coronary Stent System

The study will evaluate the performance and safety of RisoR Crest Everolimus Eluting Coronary Stent System. A total of 2000 participants will be included in the study from India and Italy.

Read the detailed description

The clinical study to evaluate safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System in Coronary Artery Stenosis in Indian (post market) and European (pre-market) Population. Enrolment of up to 1960 participants (100 QCA+50 OCT) in India and 40 in Europe is planned in the current study.

The Primary objective of the study is to evaluate the safety and performance of RisoR Crest Everolimus Eluting Coronary Stent System at 360 days follow up indicated by the Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, Target Vessel oriented Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.

The secondary objectives are-

  1. To estimate incidence of Device Oriented composite end point (DoCE) which is equivalent of Target Lesion Failure (TLF), a hierarchical composite of Cardiovascular Death, Target Vessel Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 30, 180 and 270 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System;
  2. Patient oriented composite end point (PoCE), which is a hierarchical composite of any death, any myocardial infarction, any stroke and any coronary revascularization at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.
  3. Major Adverse Cardiac Events (MACE), a hierarchical composite of cardiovascular death, Myocardial Infarction (MI) and Target Vessel Revascularization (TVR) at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.
  4. Target Vessel Failure (TVF), a hierarchical composite of cardiovascular death, Target Vessel related Myocardial Infarction (TVMI) and Clinically indicated Target Vessel Revascularization (Ci-TVR) at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.
  5. Stent thrombosis by ARC 2 and Latency Definitions at 30-, 180-, 270- and 360-days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System and
  6. To estimate
  7. Device success, defined as achievement of a final residual diameter stenosis of ≤ 20% (site - reported), using the assigned device only, with Successful deployment of stent and complete retrieval of delivery system without coronary dissection, device disintegration, visible stent malapposition.
  8. procedure success, defined as achievement of a final diameter stenosis ≤ 20%(site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay.
  9. To estimate angiographic parameters of performance of RisoR Crest Everolimus Eluting Coronary Stent System as defined by Late Lumen Loss and percentage Diameter Stenosis at 270 days.
  10. To estimate percentage of cover struts by OCT at 270 days.

All participants will be followed up at 30±8 days, 180±8 days, 270±10 days and 360±14 days.

For QCA and and OCT sub sets (only for India) all participants will have a mandatory clinic visit at 9 months (270±10 days) for a check angiography and OCT procedure.

Being tested
Coronary Stent
Keywords
RisoR Crest, Everolimus Eluting Stent, Poly Medicure Private Limited, Drug Eluting Stent, Biodegradable Polymer, Pacifier
Medical subject headings
Coronary Artery Disease, Coronary Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Coronary StentDevice

    RisoR Crest Everolimus Eluting Coronary Stent System

Study groups in NCT07098195
Study groupRoleWhat they receive
RisoR Crest Everolimus Eluting Coronary Stent SystemOtherThe RisoR Crest Everolimus Eluting Coronary Stent System is coated with a drug and biodegradable polymer coating formulation consisting of Everolimus drug, the active ingredient, and biodegradable polymers. This is intended to supply continuous release of Everolimus drug after stent implantation over an extended period of time. The unique ultrasonic atomization drug technology is combined with acoustic activation and carrier stream technologies.
Receives: Device: Coronary Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Target Lesion Failure (TLF)

    Target Lesion Failure (TLF) defined as a hierarchical composite of Cardiac Death, Target Vessel oriented Myocardial Infarction (TV-MI) and Clinically indicated Target Lesion Revascularization (Ci-TLR) at 360 days following implantation of RisoR Crest Everolimus Eluting Coronary Stent System.

    Measured: 360 Days

Secondary outcomes (8)

  1. Incidence of TLF (Equivalent of DoCE)

    1. Cardiovascular Death
    2. Target vessel Myocardial Infarction (TV-MI) and
    3. Clinically indicated Target Lesion Revascularization (Ci-TLR).

    Measured: 30, 180 and 270 days

  2. Incidence of POCE

    1. All cause death
    2. Any stroke
    3. Any myocardial infarction (includes non-target vessel territory)
    4. Any revascularization

    Measured: 30, 180, 270 and 360 days

  3. Incidence of MACE

    1. Cardiovascular death
    2. Myocardial Infarction (MI)
    3. Target Vessel Revascularization (TVR)

    Measured: 30, 180, 270 and 360 days

  4. Target Vessel Failure (TVF)

    Target Vessel Failure (TVF)

    Measured: 30, 180, 270 and 360 days

  5. Non -Target Vessel related Myocardial Infarction

    Non -Target Vessel related Myocardial Infarction

    Measured: 30, 180, 270 and 360 days

  6. Stent thrombosis

    Stent thrombosis as per

    Measured: a. Academic Research Consortium [ARC] 2 definitions - Definite/probable b. As per latency - Acute (0-24 hours), Subacute (24 hours- 30 days) and late (30-360 days)

  7. Device success

    defined as achievement of a final residual diameter stenosis of ≤ 20% (site - reported), using the assigned device only, with Successful deployment of stent and complete retrieval of delivery system without coronary dissection, device disintegration, visible stent malapposition

    Measured: Day 0

  8. Procedural success

    defined as achievement of a final diameter stenosis ≤ 20%(site-reported) using any PCI method, without the occurrence of death, MI, or repeat target vessel revascularization during hospital stay

    Measured: Day 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Aug 2025
  2. Study start18 Aug 2025 (estimated)
  3. Primary completion17 Aug 2027 (estimated)
  4. Study completion17 Jan 2028 (estimated)

Resources

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
Post-market study in India and Pre-market study in Europe.
Masking
None (open label)
Enrolment
2,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07098195
Sponsor's protocol ID
CSPL/REG/2025/02
Acronym
PACIFIER
Status last verified
Jul 2025
First submitted
12 Jul 2025
Last updated
1 Aug 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Chong B, Jayabaskaran J, Jauhari SM, Chan SP, Goh R, Kueh MTW, Li H, Chin YH, Kong G, Anand VV, Wang JW, Muthiah M, Jain V, Mehta A, Lim SL, Foo R, Figtree GA, Nicholls SJ, Mamas MA, Januzzi JL, Chew NWS, Richards AM, Chan MY. Global burden of cardiovascular diseases: projections from 2025 to 2050. Eur J Prev Cardiol. 2025 Aug 25;32(11):1001-1015. doi: 10.1093/eurjpc/zwae281.

    PubMed 39270739

  • Lee SWL, Tam FCC, Lam SCC, Kong SL, Shea CP, Chan KKW, Wong MKL, Chan MPH, Wong AYT, Yung ASY, Lam YM, Zhang LW, Wu KKY, Mintz GS, Maehara A. The OCT-ORION Study: A Randomized Optical Coherence Tomography Study Comparing Resolute Integrity to Biomatrix Drug-Eluting Stent on the Degree of Early Stent Healing and Late Lumen Loss. Circ Cardiovasc Interv. 2018 Apr;11(4):e006034. doi: 10.1161/CIRCINTERVENTIONS.117.006034.

    PubMed 29654119

  • Neumann 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 30165437

  • Mahmud E, Pourdjabbar A, Ang L, Behnamfar O, Patel MP, Reeves RR. Robotic technology in interventional cardiology: Current status and future perspectives. Catheter Cardiovasc Interv. 2017 Nov 15;90(6):956-962. doi: 10.1002/ccd.27209. Epub 2017 Aug 10.

    PubMed 28795481

  • Stefanini GG, Holmes DR Jr. Drug-eluting coronary-artery stents. N Engl J Med. 2013 Jan 17;368(3):254-65. doi: 10.1056/NEJMra1210816. No abstract available.

    PubMed 23323902

  • Prati F, Uemura S, Souteyrand G, Virmani R, Motreff P, Di Vito L, Biondi-Zoccai G, Halperin J, Fuster V, Ozaki Y, Narula J. OCT-based diagnosis and management of STEMI associated with intact fibrous cap. JACC Cardiovasc Imaging. 2013 Mar;6(3):283-7. doi: 10.1016/j.jcmg.2012.12.007.

    PubMed 23473109

  • Bangalore S, Amoroso N, Fusaro M, Kumar S, Feit F. Outcomes with various drug-eluting or bare metal stents in patients with ST-segment-elevation myocardial infarction: a mixed treatment comparison analysis of trial level data from 34 068 patient-years of follow-up from randomized trials. Circ Cardiovasc Interv. 2013 Aug;6(4):378-90. doi: 10.1161/CIRCINTERVENTIONS.113.000415. Epub 2013 Aug 6.

    PubMed 23922145

  • 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.

    PubMed 24036025

  • 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.

    PubMed 15500897

  • Mehra A, Mohan B. Value of FFR in clinical practice. Indian Heart J. 2015 Jan-Feb;67(1):77-80. doi: 10.1016/j.ihj.2015.02.025. Epub 2015 Mar 14.

    PubMed 25820058

  • Maron DJ, Hochman JS, Reynolds HR, Bangalore S, O'Brien SM, Boden WE, Chaitman BR, Senior R, Lopez-Sendon J, Alexander KP, Lopes RD, Shaw LJ, Berger JS, Newman JD, Sidhu MS, Goodman SG, Ruzyllo W, Gosselin G, Maggioni AP, White HD, Bhargava B, Min JK, Mancini GBJ, Berman DS, Picard MH, Kwong RY, Ali ZA, Mark DB, Spertus JA, Krishnan MN, Elghamaz A, Moorthy N, Hueb WA, Demkow M, Mavromatis K, Bockeria O, Peteiro J, Miller TD, Szwed H, Doerr R, Keltai M, Selvanayagam JB, Steg PG, Held C, Kohsaka S, Mavromichalis S, Kirby R, Jeffries NO, Harrell FE Jr, Rockhold FW, Broderick S, Ferguson TB Jr, Williams DO, Harrington RA, Stone GW, Rosenberg Y; ISCHEMIA Research Group. Initial Invasive or Conservative Strategy for Stable Coronary Disease. N Engl J Med. 2020 Apr 9;382(15):1395-1407. doi: 10.1056/NEJMoa1915922. Epub 2020 Mar 30.

    PubMed 32227755

  • Boden WE, O'Rourke RA, Teo KK, Hartigan PM, Maron DJ, Kostuk WJ, Knudtson M, Dada M, Casperson P, Harris CL, Chaitman BR, Shaw L, Gosselin G, Nawaz S, Title LM, Gau G, Blaustein AS, Booth DC, Bates ER, Spertus JA, Berman DS, Mancini GB, Weintraub WS; COURAGE Trial Research Group. Optimal medical therapy with or without PCI for stable coronary disease. N Engl J Med. 2007 Apr 12;356(15):1503-16. doi: 10.1056/NEJMoa070829. Epub 2007 Mar 26.

    PubMed 17387127

  • Serruys PW, Morice MC, Kappetein AP, Colombo A, Holmes DR, Mack MJ, Stahle E, Feldman TE, van den Brand M, Bass EJ, Van Dyck N, Leadley K, Dawkins KD, Mohr FW; SYNTAX Investigators. Percutaneous coronary intervention versus coronary-artery bypass grafting for severe coronary artery disease. N Engl J Med. 2009 Mar 5;360(10):961-72. doi: 10.1056/NEJMoa0804626. Epub 2009 Feb 18.

    PubMed 19228612

  • Mauri L, Orav EJ, Candia SC, Cutlip DE, Kuntz RE. Robustness of late lumen loss in discriminating drug-eluting stents across variable observational and randomized trials. Circulation. 2005 Nov 1;112(18):2833-9. doi: 10.1161/CIRCULATIONAHA105.570093.

    PubMed 16267256

  • Hou XM, Han WZ, Qiu XB, Chen H, Fang WY. Safety and effectiveness of drug-eluting stents in Chinese patients with coronary artery disease with off- and on-label indications: results from a single-centre registry. Heart Asia. 2013 Jan 24;5(1):101-5. doi: 10.1136/heartasia-2013-010316. eCollection 2013.

    PubMed 27326098

Questions about this trial

What is this clinical trial studying?

A study testing Coronary Stent in people with Coronary Artery Disease and Coronary Artery Stenosis, run by Poly Medicure Limited.

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 11 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 1 Aug 2025. 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 Dinesh Rajendra Patil (+91-8149037128, dinesh.patil@polymedicure.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Target Lesion Failure (TLF) (time frame: 360 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 NCT07098195, which also lists 16 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 1 Aug 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in