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 range
18 Years
Sex
ALL
See this in plain English?
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)…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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).