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)

August 4, 2026 updated by: Fundación EPIC

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

94

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Barcelona, Spain, 08035
        • Recruiting
        • Hospital Universitari Vall d'Hebron
      • Gijón, Spain, 33394
        • Recruiting
        • Hospital Universitario de Cabuenes
      • Huelva, Spain, 21005
        • Recruiting
        • Hospital Universitario Juan Ramon Jimenez
      • León, Spain, 24008
        • Recruiting
        • Hospital Universitario de Leon
      • Lugo, Spain, 270003
        • Recruiting
        • Hospital Universitario Lucus Augusti
      • Oviedo, Spain, 33011
        • Recruiting
        • Hospital Universitario Central de Asturias
      • Pontevedra, Spain, 36071
        • Recruiting
        • Hospital Provincial de Pontevedra
      • Tarragona, Spain, 43005
        • Recruiting
        • Hospital Universitari de Tarragona Joan XXIII

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Drug Coated Balloon (DCB)
Device: Drug Coated Balloon (DCB)
Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
Experimental: Drug Eluting Stent (DES)
Device: Drug Eluting Stent (DES)
Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Time Frame: 8 months
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of percentage of angiographic restenosis by quantitative coronary
Time Frame: 8 months
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
Time Frame: 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
Time Frame: 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
Time Frame: 8 months
Percentage of of strut coverage by OCT 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
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación EPIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

June 4, 2024

First Submitted That Met QC Criteria

June 4, 2024

First Posted (Actual)

June 7, 2024

Study Record Updates

Last Update Posted (Actual)

August 5, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EPIC37-DEBORA

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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