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Recruiting NCT06448637

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)

Conditions: Coronary Artery Disease

Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 94
Sponsor: Fundación EPIC

Location: Hospital Universitari Vall d'Hebron Barcelona

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

Eligibility Criteria

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 \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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06448637). StuddyBuddy aggregates publicly available trial information.