NCT05292092

Brief Summary

Multicenter, 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
161

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2022

Typical duration for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 23, 2022

Completed
6 months until next milestone

Study Start

First participant enrolled

September 26, 2022

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 29, 2025

Completed
20 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2026

Completed
Last Updated

January 21, 2026

Status Verified

January 1, 2026

Enrollment Period

3.3 years

First QC Date

March 14, 2022

Last Update Submit

January 19, 2026

Conditions

Ischemic Heart DiseaseCoronary Artery Disease (CAD)

Keywords

MDR (Medical Device Regulations)PMCF (Post-Market Clinical Follow-up)Paclitaxel eluting coronary balloon dilatation catheter

Outcome Measures

Primary Outcomes (1)

  • Safety Endpoint. Freedom from Target Lesion Failure

    Freedom from TARGET LESION FAILURE (TLF), composite endpoint of cardiac death, myocardial infarction (MI) and a new Target Lesion Revascularization (TLR).

    12 months

Secondary Outcomes (8)

  • Efficacy Endpoint. Freedom from Target Lesion Failure (TLF)

    12 months

  • Freedom from Balloon rupture

    During percutaneous coronary intervention (PCI)

  • Freedom from Hypotube rupture

    During PCI

  • Freedom from Complicated withdrawal

    During PCI

  • Freedom from Coronary perforation

    During PCI

  • +3 more secondary outcomes

Study Arms (1)

Coronary Artery Disease (CAD)

Drug: Essential pro

Interventions

Essential proDRUG

Patients in whom treatment with (Essential Pro) has been attempted

Coronary Artery Disease (CAD)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients treated with Essential Pro according to routine hospital practice and following instructions for use

You may qualify if:

  • Patient treated with Essential Pro according to routine hospital practice and following instructions for use
  • Informed consent signed

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Hospital Punta de Europa

Algeciras, 11207, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario de Jerez de la Frontera

Jerez de la Frontera, 11407, Spain

Location

Hospital Universitario de Leon

León, 24080, Spain

Location

Hospital Universitario Regional de Malaga

Málaga, 29010, Spain

Location

Hospital Universitario de Puerto Real

Puerto Real, 11510, Spain

Location

Hospital Universitario Marques de Valdecilla

Santander, 39008, Spain

Location

Related Publications (3)

  • 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.

    PMID: 74678BACKGROUND

  • Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Leibundgut G, Weilenmann D, Wohrle J, Richter S, Schreiber M, Mahfoud F, Linke A, Stephan FP, Mueller C, Rickenbacher P, Coslovsky M, Gilgen N, Osswald S, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Drug-coated balloons for small coronary artery disease (BASKET-SMALL 2): an open-label randomised non-inferiority trial. Lancet. 2018 Sep 8;392(10150):849-856. doi: 10.1016/S0140-6736(18)31719-7. Epub 2018 Aug 28.

    PMID: 30170854BACKGROUND

  • 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.

    PMID: 33953973BACKGROUND

MeSH Terms

Conditions

Coronary Artery DiseaseMyocardial Ischemia

Condition Hierarchy (Ancestors)

Coronary DiseaseHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 14, 2022

First Posted

March 23, 2022

Study Start

September 26, 2022

Primary Completion

December 29, 2025

Study Completion

January 18, 2026

Last Updated

January 21, 2026

Record last verified: 2026-01

Locations

ES(7)