Clinical trial NCT06631157: Essential Pro Study ( rEPIC04E-HK )
Official title: Essential Pro Post-Market Clinical Follow-up Study
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Coronary Artery Disease
Ischemic Heart Disease
Keywords: MDR (Medical Device Regulations)
PMCF (Post-Market Clinical Follow-up)
Paclitaxel eluting coronary balloon dilatation catheter
Lead sponsor: Fundación EPIC
Sponsor class: OTHER
First posted: 2024-10-08
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients treated with Essential Pro according to routine hospital practice and following instructions for use

Brief summary: Single center, prospective, non-randomized, post-market clinical follow-up (PMCF) study to confirm and support the clinical safety and performance of Essential Pro to meet EU Medical Device regulation (MDR) requirements in all the CONSECUTIVE patients treated with Essential Pro.

Detailed description: This study intends to analyze:

* Device effectiveness (in its individual use, technical performance) and procedural effectiveness (technical outcome at the end of lesion treatment with the device under study and any other device being used).
* Device safety (in its individual use, technical performance) and procedural safety (technical outcome at the end of lesion treatment with the device under study and any other device being used).
* Clinical outcomes at the end of the procedure and during the specified follow-up period for each device. The follow-up timeframe is established based on the conditions of use and type of device being used, according to the requirements established by the relevant Notified Body.

Eligibility 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

Primary outcomes:
measure: Safety Endpoint. Freedom from Target Lesion Failure
timeFrame: 12 months
Secondary outcomes:
measure: Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)
timeFrame: 12 months
measure: Freedom from Balloon rupture
timeFrame: During PCI
measure: Freedom from Hypotube rupture
timeFrame: During PCI
measure: Freedom from Complicated withdrawal
timeFrame: During PCI
measure: Freedom from Coronary perforation
timeFrame: During PCI
measure: Freedom from Coronary dissection >C
timeFrame: During PCI
measure: Freedom from No reflow
timeFrame: During PCI
measure: Freedom from Coronary thrombosis
timeFrame: During PCI
Other outcomes:
Locations:
Study officials:
References:
citation: Gruntzig A. Transluminal dilatation of coronary-artery stenosis. Lancet. 1978 Feb 4;1(8058):263. doi: 10.1016/s0140-6736(78)90500-7. No abstract available.
citation: Wu X, Li L, He L. Drug-Coated Balloon versus Drug-Eluting Stent in Patients with Small-Vessel Coronary Artery Disease: A Meta-Analysis of Randomized Controlled Trials. Cardiol Res Pract. 2021 Apr 13;2021:1647635. doi: 10.1155/2021/1647635. eCollection 2021.