Post-market follow-up of Coroflex® ISAR NEO coronary stent system

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This international, multicenter, prospective, non-randomized study aims to confirm the clinical safety and performance of the Coroflex® ISAR NEO coronary stent system in real-world patients. It will involve consecutive patients treated with the sirolimus-eluting stent to ensure compliance with EU Medical Device regulations. The study will gather data under daily clinical practice conditions to evaluate the stent's effectiveness and safety.

Why it matters

Who can join: the full rules

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

Where it's running

• 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

Study contacts

• Study coordinator: koldobika García San Román, MD, PhD
• Email: koldobikags@hotmail.com
• Phone: 0034696704643

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.