DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTIO… (NCT06448637) | Clinical Trial Compass
RecruitingNot Applicable
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)
Spain94 participantsStarted 2024-10-23
Plain-language 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
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)…
What they're measuring
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).