---
title: Coroflex® ISAR NEO PMCF Study
nct_id: NCT05698732
overall_status: RECRUITING
sponsor: Fundación EPIC
study_type: OBSERVATIONAL
primary_condition: Coronary Artery Disease (CAD)
countries: France, Spain
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT05698732.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT05698732"
ct_last_update_post_date: 2026-05-01
last_seen_at: "2026-05-12T07:25:01.284Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Coroflex® ISAR NEO PMCF Study

**Official Title:** Coroflex® ISAR NEO Coronary Stent System Post-Market Clinical Follow-up Study

**NCT ID:** [NCT05698732](https://clinicaltrials.gov/study/NCT05698732)

## Key Facts

- **Status:** RECRUITING
- **Study Type:** OBSERVATIONAL
- **Target Enrollment:** 3000
- **Lead Sponsor:** Fundación EPIC
- **Conditions:** Coronary Artery Disease (CAD), Ischemic Heart Disease
- **Start Date:** 2023-08-04
- **Completion Date:** 2027-02-01
- **CT.gov Last Update:** 2026-05-01

## Brief Summary

International, Multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Coroflex® ISAR NEO coronary stent system to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Coroflex® ISAR NEO coronary stent system sirolimus eluting stent.

## Detailed Description

The objective of this international, multicenter, prospective, non-randomized, post-market clinical follow-up (PMCF) study is to confirm and support the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system Sirolimus Eluting Stent in a NON-SELECTED, Real World population under daily clinical practice when used as intended by the manufacturer to meet EU Medical Device regulation requirements for post-market clinical follow-up.

## Eligibility

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Inclusion Criteria:

Coroflex® ISAR NEO is intended to be used for

* Patients must be at least 18 years of age AND
* 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 AND
* Patients with Novo lesion length 2-4 mm AND
* Informed consent signed

Exclusion Criteria:

* Patients with express refusal by the patient to participate in the study.
* Patients pregnant women and lactating women.
* Patients with acute coronary syndrome (ACS) in a situation of cardiogenic shock (Killip 4).
* Patients in whom anti-platelet and/or anti-coagulation therapy is contraindicated
* Patients with lesions, that possibly can not be treated successfully with Percutaneous transluminal Coronary Angioplasty (PTCA) or stent implantation
* Patients with known sensitivity to Sirolimus, the carrier Probucol, the procedural co-medication or the alloying component of the stent
* Patients with known sensitivity to contrast agents who cannot be premedicated.
* Patients with contraindications or hypersensitivity to sirolimus
* Patients with a life expectancy of less than 2 years
* Patients included in other clinical trials
```

## Arms

- **Coronary Artery Disease (CAD) and high risk of bleeding**
- **Coronary Artery Disease (CAD)**

## Interventions

- **Coroflex® ISAR NEO coronary stent system** (DEVICE) — Patients in whom treatment with Coroflex® ISAR NEO coronary stent system has been attempted

## Primary Outcomes

- **Safety Endpoint. Freedom from Target Lesion Failure** _(time frame: 7 days)_ — Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, stent thrombosis (Academic Research Consortium definitive/ probable), and new Target Lesion Revascularization (TLR)
- **Efficacy Endpoint. Freedom fromTarget Lesion Failure** _(time frame: 7 days)_ — Freedom from TARGET LESION FAILURE (TLF), composite endpoint of Cardiac death, Myocardial infarction, and new Target Lesion Revascularization (TLR).

## Secondary Outcomes

- **Freedom from Accidental dislodgement of the stent** _(time frame: During percutaneous coronary intervention (PCI))_
- **Freedom from Balloon rupture** _(time frame: During PCI)_
- **Freedom from Hypotube rupture** _(time frame: During PCI)_
- **Freedom from Complicated withdrawal** _(time frame: During PCI)_
- **Freedom from Coronary perforation** _(time frame: During PCI)_
- **Freedom from Coronary dissection >C** _(time frame: During PCI)_
- **Freedom from No reflow** _(time frame: During PCI)_
- **Freedom from Coronary thrombosis** _(time frame: During PCI)_

## Locations (22)

- Centre Hospitalier du Pays d'Aix, Aix-en-Provence, France — _RECRUITING_
- Centre Hospitalier Ajaccio, Ajaccio, France — _RECRUITING_
- CH Polyclinique Bordeaux Nord Aquitaine, Bordeaux, France — _RECRUITING_
- University Hospital Center of Caen, Caen, France — _RECRUITING_
- Hôpital Albert Schweitzer, Colmar, France — _RECRUITING_
- Hospitalario Universitario (CHU) de Lille, Lille, France — _RECRUITING_
- APHP -Hôpital Lariboisière, Paris, France — _RECRUITING_
- Institut Arnault Tzanck, Saint-Laurent-du-Var, France — _RECRUITING_
- Hospital Universitario A Coruña, A Coruña, Spain — _RECRUITING_
- Hospital Universitario de Badajoz, Badajoz, Spain — _RECRUITING_
- Hospital Universitari Germans Trias I Pujol, Badalona, Spain — _RECRUITING_
- Hospital Universitario de Cruces, Barakaldo, Spain — _RECRUITING_
- Hospital de la Santa Creu i Sant Pau, Barcelona, Spain — _RECRUITING_
- Hospital Universitari Vall D Hebron, Barcelona, Spain — _RECRUITING_
- Hospital Universitario San Pedro de Alcantara, Cáceres, Spain — _RECRUITING_
- Hospital General Universitario de Ciudad Real, Ciudad Real, Spain — _RECRUITING_
- Hospital Universitario Juan Ramon Jimenez, Huelva, Spain — _RECRUITING_
- Hospital Universitario de Leon, León, Spain — _RECRUITING_
- Hospital Universitario Lucus Agusti, Lugo, Spain — _RECRUITING_
- Hospital Regional Universitario de Málaga, Málaga, Spain — _RECRUITING_
- Hospital Universitario Virgen de la Victoria, Málaga, Spain — _RECRUITING_
- Hospital Clinico Universitario Lozano Blesa, Zaragoza, Spain — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.centre hospitalier du pays d'aix|aix-en-provence||france` — added _(2026-05-12)_
- `locations.centre hospitalier ajaccio|ajaccio||france` — added _(2026-05-12)_
- `locations.ch polyclinique bordeaux nord aquitaine|bordeaux||france` — added _(2026-05-12)_
- `locations.university hospital center of caen|caen||france` — added _(2026-05-12)_
- `locations.hôpital albert schweitzer|colmar||france` — added _(2026-05-12)_
- `locations.hospitalario universitario (chu) de lille|lille||france` — added _(2026-05-12)_
- `locations.aphp -hôpital lariboisière|paris||france` — added _(2026-05-12)_
- `locations.institut arnault tzanck|saint-laurent-du-var||france` — added _(2026-05-12)_
- `locations.hospital universitario a coruña|a coruña||spain` — added _(2026-05-12)_
- `locations.hospital universitario de badajoz|badajoz||spain` — added _(2026-05-12)_
- `locations.hospital universitari germans trias i pujol|badalona||spain` — added _(2026-05-12)_
- `locations.hospital universitario de cruces|barakaldo||spain` — added _(2026-05-12)_
- `locations.hospital de la santa creu i sant pau|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitari vall d hebron|barcelona||spain` — added _(2026-05-12)_
- `locations.hospital universitario san pedro de alcantara|cáceres||spain` — added _(2026-05-12)_
- `locations.hospital general universitario de ciudad real|ciudad real||spain` — added _(2026-05-12)_
- `locations.hospital universitario juan ramon jimenez|huelva||spain` — added _(2026-05-12)_
- `locations.hospital universitario de leon|león||spain` — added _(2026-05-12)_
- `locations.hospital universitario lucus agusti|lugo||spain` — added _(2026-05-12)_
- `locations.hospital regional universitario de málaga|málaga||spain` — added _(2026-05-12)_
- `locations.hospital universitario virgen de la victoria|málaga||spain` — added _(2026-05-12)_
- `locations.hospital clinico universitario lozano blesa|zaragoza||spain` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT05698732.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT05698732*  
*This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*