Post-market follow-up for Essential Pro coronary balloon catheter
Essential Pro Post-Market Clinical Follow-up Study
Fundación EPIC · NCT05292092
This study is testing how safe and effective the Essential Pro balloon catheter is for patients in real-life situations after it has been approved for use.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 176 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Fundación EPIC (other) |
| Locations | 7 sites (Algeciras and 6 other locations) |
| Trial ID | NCT05292092 on ClinicalTrials.gov |
What this trial studies
This multicenter, prospective, non-randomized observational study aims to confirm the clinical safety and performance of the Essential Pro paclitaxel-eluting coronary balloon dilatation catheter in a real-world population. It involves consecutive patients treated with the device in routine clinical practice, ensuring that the study reflects everyday use. The study is designed to meet EU Medical Device regulation requirements for post-market clinical follow-up, providing valuable data on the device's effectiveness and safety.
Who should consider this trial
Good fit: Ideal candidates for this study are patients who are treated with the Essential Pro catheter according to routine hospital practice and have provided informed consent.
Not a fit: Patients who do not meet the inclusion criteria or those who are not treated with the Essential Pro catheter will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of the Essential Pro device's safety and effectiveness, potentially leading to improved 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 performance, making this approach well-established.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patient treated with Essential Pro according to routine hospital practice and following instructions for use * Informed consent signed Exclusion Criteria: • Not meet inclusion criteria
Where this trial is running
Algeciras and 6 other locations
- Hospital Punta de Europa — Algeciras, Spain (RECRUITING)
- Hospital Clinic de Barcelona — Barcelona, Spain (RECRUITING)
- Hospital Universitario de Jerez de la Frontera — Jerez De La Frontera, Spain (RECRUITING)
- Hospital Universitario de Leon — León, Spain (RECRUITING)
- Hospital Universitario Regional de Malaga — Málaga, Spain (RECRUITING)
- Hospital Universitario de Puerto Real — Puerto Real, Spain (RECRUITING)
- Hospital Universitario Marques de Valdecilla — Santander, Spain (RECRUITING)
Study contacts
- Study coordinator: FUNDACION EPIC
- Email: iepic@fundacionepic.org
- Phone: 987225638
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