Coroflex ISAR NEO "All Comers" Post Market Clinical Follow-up (PMCF)

Post-marketing Clinical Follow-up Study With Coroflex® ISAR Neo

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

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease
• Intervention / Treatment: Device: Coroflex® ISAR NEO coronary stent system

Detailed Description

Post-authorisation / after Conformité Européene (CE) marking Coroflex® ISAR NEO is a drug eluting stent system which is an improved version of the predecessor device Coroflex® ISAR which was extensively studied in the ISAR 2000 Registry. The rationale of this observational, post-market, single-armed study is to confirm the safety and efficacy of Coroflex® ISAR NEO, also as part of the manufacturer's post-market surveillance obligations in particular for the re-certification of the device.

• Study Type: Observational
• Enrollment (Actual): 3520

Contacts and Locations

Study Locations

• France
  • Rouen, France, 76000
    • Clinique St. Hilaire

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-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".

Description

Inclusion Criteria:

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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Target Lesion Revascularization (TLR) rate at 12 months	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accumulated Major Adverse Cardiovascular Events (MACE) rate at 12 months (including intra-hospital events)	MACE consists of all events TLR (Re-Percutaneous Coronary Intervention (Re-PCI), Coronary Artery Bypass Grafting (CABG)), Myocardial Infarction (MI), cardiac death (inhospital) and all-cause death up to 12 months. MI is defined as a new event documented with elevated cardiac enzymes during the follow-up. Elevated enzyme levels during the hospital stay are not considered as a new event.	12 months
Accumulated Target Vessel Failure Rate at 12 months (including intra-hospital events)		12 months
Stent thrombosis rates accumulated up to 12 months	Stent thrombosis is defined as thrombosis in the treated coronary lesion only. No venous thrombotic events are relevant for this end point.	12 months
Rate of bleeding complications accumulated up to 12 months	To assess the bleeding complications the Bleeding Academic Research Consortium (BARC) scale will be used.	12 months
Technical/procedural success rate		immediately after procedure

Collaborators and Investigators

• Sponsor: B. Braun Melsungen AG
• Investigators: Principal Investigator: Rene Koning, MD, Clinique St. Hilaire

Study record dates

Study Major Dates

• Study Start (Actual): January 17, 2019
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: January 17, 2019
• First Submitted That Met QC Criteria: January 17, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 11, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Disease; Coronary Artery Disease
• Other Study ID Numbers: AAG-O-H-1803

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No