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NCT06448637Recruiting

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)

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Study type
Interventional
Enrollment
94 (estimated)
First submitted
4 Jun 2024
Start date
23 Oct 2024
Primary completion date
1 Dec 2026
Lead sponsor
Fundación EPIC
NCT number
NCT06448637

What you commit to

  • Study type: Interventional
  • Planned participants: 94
  • From 23 Oct 2024 to the primary completion date, 1 Dec 2026
  • 9 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Patients who received a combination of DES and DCB in the same vessel

Other illness

  • Patients who meet at least one of the following conditions are excluded:
  • 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 with symptomatic congestive heart failure.
  • Patients with significant autoimmune inflammatory conditions and patients taking immunomodulatory medications (including methotrexate, cyclosporine, steroids).
  • Patients with heart transplant.

Lab values

  • Patients with anemia (Hb \<12 g/dL in men and \<10 g/dL in women).

Age

  • Patients, women of childbearing age with a positive pregnancy test.

Other

  • Patients with any contraindication for the administration of acetylcholine (ACh) or nitroglycerin (NTG).
  • 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).
  • Pregnant female patients.
  • Patients included in other clinical trials with active follow-up.

Who the study is looking for

  • 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.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (9)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Universitari Vall d'Hebron
Coordinator of this site? Confirm its status
BarcelonaSpainRecruiting
Hospital Universitario de Cabueñes
Coordinator of this site? Confirm its status
GijónSpainRecruiting
Hospital Universitario Juan Ramon Jimenez
Coordinator of this site? Confirm its status
HuelvaSpainRecruiting
Hospital Universitario De Leon
Coordinator of this site? Confirm its status
LeónSpainRecruiting
Hospital Universitario Lucus Augusti
Coordinator of this site? Confirm its status
LugoSpainRecruiting
Hospital de Mérida
Coordinator of this site? Confirm its status
MéridaSpainRecruiting
Hospital Universitario Central De Asturias
Coordinator of this site? Confirm its status
OviedoSpainRecruiting
Hospital Provincial de Pontevedra
Coordinator of this site? Confirm its status
PontevedraSpainRecruiting
Hospital Universitari de Tarragona Joan XXIII
Coordinator of this site? Confirm its status
TarragonaSpainRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.