Observational study on the Sequent Please Neo balloon catheter for heart disease
Sequent Please Neo Extended Post-Market Clinical Follow-up Study
Fundación EPIC · NCT05788432
This study is testing how safe and effective the Sequent Please Neo balloon catheter is for people with coronary artery disease and ischemic heart disease in real-life situations.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2028 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC (other) |
| Locations | 27 sites (Alava and 26 other locations) |
| Trial ID | NCT05788432 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, non-randomized observational study aims to confirm the clinical safety and performance of the Sequent Please Neo balloon catheter in patients with coronary artery disease and ischemic heart disease. It will involve consecutive patients treated with this device in real-world clinical settings, adhering to the manufacturer's instructions. The study is designed to meet EU Medical Device Regulation requirements for post-market clinical follow-up, ensuring that the device's effectiveness and safety are evaluated in a diverse patient population.
Who should consider this trial
Good fit: Ideal candidates for this study are patients with coronary artery disease who are treated with the Sequent Please Neo catheter and can provide informed consent.
Not a fit: Patients with a life expectancy of less than 12 months or contraindications for antiplatelet therapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable data supporting the safety and effectiveness of the Sequent Please Neo catheter, potentially improving treatment options for patients with coronary artery disease.
How similar studies have performed: Other studies involving post-market clinical follow-up of medical devices have shown success in confirming safety and efficacy, making this approach a continuation of established practices.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients treated with Sequent please neo according to routine hospital practice and following instruction for use. * Informed Consent Signed. Exclusion Criteria: * Patient life expectancy less than 12 months. * Contraindication for antiplatelet therapy. * Not meet inclusion criteria.
Where this trial is running
Alava and 26 other locations
- Hospital Universitario de Araba — Alava, Spain (RECRUITING)
- Hospital General Universitario de Alicante Dr.Balmis — Alicante, 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 Y Sant Pau — Barcelona, Spain (RECRUITING)
- Hospital Clinic de Barcelona — Barcelona, Spain (RECRUITING)
- Hospital Universitario Puerta Del Mar — Cadiz, Spain (RECRUITING)
- Hospital General Universitari de Castelló — Castelló, Spain (RECRUITING)
- Hospital Universitario San Pedro de Alcantara — Cáceres, Spain (RECRUITING)
- Hospital Universitario de Ciudad Real — Ciudad Real, Spain (RECRUITING)
- Hospital General Universitario de Elche — Elche, Spain (RECRUITING)
- Hospital Universitario de Cabueñes — Gijón, Spain (RECRUITING)
- Hospital Universitari Dr. Josep Trueta — Girona, Spain (RECRUITING)
- Hospital Universitario Juan Ramon Jimenez — Huelva, Spain (RECRUITING)
- Hospital Universitario de Jaen — Jaén, Spain (RECRUITING)
- Hospital Universitario de Leon — León, Spain (RECRUITING)
- Hospital Universitario Lucus Agusti — Lugo, Spain (RECRUITING)
- Hospital Universitario de La Princesa — Madrid, Spain (RECRUITING)
- Hospital Universitario 12 de Octubre — Madrid, Spain (RECRUITING)
- Hospital Regional Universitario de Malaga — Málaga, Spain (RECRUITING)
- Hospital Universitario Virgen de La Victoria — Málaga, Spain (RECRUITING)
- Hospital de Mérida — Mérida, Spain (RECRUITING)
- Hospital Universitario Puerto Real — Puerto Real, Spain (RECRUITING)
- Hospital Clinico Universitario de Salamanca — Salamanca, Spain (RECRUITING)
- Hospital Universitario Virgen Del Rocio — Seville, Spain (RECRUITING)
- Hospital General Universitario de Toledo — Toledo, Spain (RECRUITING)
Study contacts
- Study coordinator: ORIOL RODRIGUEZ LEOR, MD, PhD
- Email: oriolrodriguez@gmail.com
- Phone: 0034934651200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Coronary Artery Disease, Ischemic Heart Disease, MDR, PMCF, Paclitaxel eluting coronary balloon dilatation catheter