NCT03809715

Brief Summary

The aim of the study is to assess the safety and efficacy of the device to treat coronary de novo and restenotic lesions.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,520

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2019

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2019

Completed
Same day until next milestone

Study Start

First participant enrolled

January 17, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 18, 2019

Completed
5.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2024

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2025

Completed
Last Updated

January 8, 2026

Status Verified

January 1, 2026

Enrollment Period

5.4 years

First QC Date

January 17, 2019

Last Update Submit

January 7, 2026

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

  • Target Lesion Revascularization (TLR) rate at 12 months

    12 months

Secondary Outcomes (5)

  • Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)

    12 months

  • Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)

    12 months

  • Stent thrombosis rates accumulated up to 12 months

    12 months

  • Rate of bleeding complications accumulated up to 12 months

    12 months

  • Technical/procedural success rate

    immediately after procedure

Interventions

Coroflex® ISAR NEO coronary stent systemDEVICE

treatment of coronary artery disease with Coroflex® ISAR NEO of "real world" de-novo and restenotic lesions in native coronary arteries and coronary bypass grafts

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

The investigator of each study site has the responsibility of screening all potential patients and selecting those who fulfil the inclusion criteria of this study protocol. Therefore, at each site a study with similar inclusion criteria cannot be conducted while the recruitment of this study is in progress. Screening will be performed during the physical examination to verify the "patient related enrolment criteria". The second part of the screening procedure will be completed during the diagnostic angiography to verify that the target lesion fulfils all "lesion related enrolment criteria".

You may qualify if:

  • Coroflex® ISAR NEO is intended to be used for
  • All common significant coronary lesions
  • Target lesion length \>34mm need to be covered with at least 2 stents
  • Patients eligible for this study must be at least 18 years of age.
  • The patient must fulfill the standard recommendations for Percutaneous Coronary Intervention (PCI) based on the last European Society of Cardiology (ESC) recommendations within his/ her regular treatment or that the use of the product has already been decided within the regular planning of the patient's treatment.

You may not qualify if:

  • Intolerance to sirolimus and/or probucol
  • Allergy to components of the coating
  • Pregnancy and lactation
  • Complete occlusion of the treatment vessel because of an unsuccessfully re-canalized
  • Cardiogenic shock
  • Risk of an intraluminal thrombus
  • Hemorrhagic diathesis or another disorder such as gastro-intestinal ulceration or cerebral circulatory disorders which restrict the use of platelet aggregation inhibitor therapy and anti-coagulation therapy
  • Surgery shortly after myocardial infarction with indications of thrombus or poor coronary flow behavior
  • Severe allergy to contrast media
  • Lesions which are untreatable with PCI or other interventional techniques
  • Patients with an ejection fraction of \< 30 %
  • Vascular reference diameter \< 2.00 mm
  • Treatment of the left stem (first section of the left coronary artery)
  • Indication for a bypass surgery
  • Contraindication for whichever accompanying medication is necessary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique St. Hilaire

Rouen, 76000, France

Location

Related Publications (1)

  • Landolff Q, Quillot M, Picard F, Henry P, Sideris G, Bizeau O, Piot C, Jouve B, Rischner J, Mejri M, Charmasson C, Lasserre R, Pouliquen H, Joseph T, Monsegu J, Karsenty B, Martin Yuste V, Richet N, Lapeyre G, Beverelli F, Beygui F, Koning R. In-Hospital and 1-Year Clinical Results from the French Registry Using Polymer-Free Sirolimus-Eluting Stents in Acute Coronary Syndrome and Stable Coronary Artery Disease. J Interv Cardiol. 2023 Dec 13;2023:8907315. doi: 10.1155/2023/8907315. eCollection 2023.

    PMID: 38125031DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Officials

  • Rene Koning, MD

    Clinique St. Hilaire

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2019

First Posted

January 18, 2019

Study Start

January 17, 2019

Primary Completion

May 31, 2024

Study Completion

August 15, 2025

Last Updated

January 8, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)