DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY) IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

NCT06448637 | Recruiting DMC

• 1 other identifier: EPIC37-DEBORA
• Study Type: interventional
• Target: 94
• Locations: 1 country
• Sites: 7

Brief Summary

Randomized, controlled, open and multicenter study that analyzes the vasomotor function 8 months after use of the drug-eluting balloon (DCB) vs. drug-eluting stent (DES) in vessels ≥ 3.5 mm

Conditions

Coronary Artery Disease

Keywords

Drug-coated balloon; Vasomotor function

Outcome Measures

Primary Outcomes (1)

• Percentage of vessels with a positive response to Ach, defined as >4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).

  Percentage of vessels with a positive response to Ach, defined as \>4% change in the mean luminal diameter observed in the coronary segment distal (10-30 mm) to the treated segment, after the infusion of the maximum dose of ACh (10-6 mol/L).

  8 months

Secondary Outcomes (5)

• Comparison of percentage of angiographic restenosis by quantitative coronary

  8 months

• Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography

  8 months

• Comparison of the minimum luminal area of the treated segment by optical coronary tomography

  8 months

• Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group

  8 months

• Percentage of vessels with normal vascular architecture with correct definition of intima and media by optical coherence tomography in the drug-coated balloon group at 8 months

  8 months

Study Arms (2)

Drug Coated Balloon (DCB)

ACTIVE COMPARATOR

Drug Coated Balloon (DCB)

Device: Drug Coated Balloon (DCB)

Drug Eluting Stent (DES)

EXPERIMENTAL

Drug Eluting Stent (DES)

Device: Drug Eluting Stent (DES)

Interventions

Drug Coated Balloon (DCB) DEVICE

Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)

Drug Coated Balloon (DCB)

Drug Eluting Stent (DES) DEVICE

Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

Drug Eluting Stent (DES)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who meet all of the following conditions are included.
• Patients aged ≥ 18 years and;
• Patients with chronic coronary syndrome, acute coronary syndrome without ST segment elevation or acute coronary syndrome with elevation ST segment in non-culprit lesions 48 hours after the event and;
• Patients with de novo lesions in vessels ≥ 3.5 mm without calcification significant no visible thrombus and;
• Patients who have been informed of the characteristics of the study and have provided their written informed consent.

You may not qualify if:

• Patients who meet at least one of the following conditions are excluded:
• Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
• Patients with a history of coronary vasospasm or spontaneous dissection of the coronary artery.
• Patients with significant medical, surgical or psychiatric condition that would affect the safety of the subject or influence the outcome of the study according to the doctor's opinion.
• Patients who received a combination of DES and DCB in the same vessel
• Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2
• Patients with body mass index \>35 (may affect the evaluation qualitative diameter of the coronary artery).
• Patients with symptomatic congestive heart failure.
• Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
• Patients with heart transplant.
• Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women).
• Patients, women of childbearing age with a positive pregnancy test.
• Pregnant female patients.
• Patients included in other clinical trials with active follow-up.

Sponsors & Collaborators

• Fundación EPIC: lead

Study Sites (7)

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario de Cabueñes

Gijón, 33394, Spain

RECRUITING

Hospital Universitario Juan Ramón Jiménez

Huelva, 21005, Spain

RECRUITING

Hospital Universitario de Leon

León, 24008, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, 270003, Spain

RECRUITING

Hospital Universitario Central de Asturias

Oviedo, 33011, Spain

RECRUITING

Hospital Provincial de Pontevedra

Pontevedra, 36071, Spain

RECRUITING

Related Publications (5)

• Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046.

  PMID: 32138967 BACKGROUND

• Nakamura T, Brott BC, Brants I, Panchal D, Li J, Chen JP, King SB 3rd, Chronos N, Hou D. Vasomotor function after paclitaxel-coated balloon post-dilation in porcine coronary stent model. JACC Cardiovasc Interv. 2011 Feb;4(2):247-55. doi: 10.1016/j.jcin.2010.08.028.

  PMID: 21349465 BACKGROUND

• Gutierrez E G-LJ, Escaned J, Cruz I, Ojeda S, Romaguera R, Moreno R. Valoración de la función endotelial y provocación de vasoespasmo coronario mediante infusión intracoronaria de acetilcolina. Documento técnico de la ACI-SEC. REC Interv Cardiol. 2021;3(4):286-296.

  BACKGROUND

• Gomez-Lara J, Oyarzabal L, Ortega-Paz L, Brugaletta S, Romaguera R, Salvatella N, Roura G, Rivero F, Fuentes L, Alfonso F, Otaegui I, Vandeloo B, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation. J Am Heart Assoc. 2021 Nov 16;10(22):e022123. doi: 10.1161/JAHA.121.022123. Epub 2021 Nov 3.

  PMID: 34729992 BACKGROUND

• Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J. 2012 Jun;33(11):1325-33. doi: 10.1093/eurheartj/ehr466. Epub 2012 Apr 16.

  PMID: 22507972 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Drug-Eluting Stents

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Stents; Prostheses and Implants; Equipment and Supplies

Central Study Contacts

IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD

CONTACT

0034630901145; inigo.lozano@fundacionepic.org

FUNDACION EPIC

CONTACT

0034987876135; iepic@fundacionepic.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2024
• First Posted: June 7, 2024
• Study Start: October 23, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 23, 2026

Record last verified: 2026-03

Locations

ES (7)