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New treatment option for Coronary Artery Disease
Official title 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)
ClinicalTrials.gov ID: NCT06448637
What this study is testing
- What it's testing
- 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
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- 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...
- Patients who received a combination of DES and DCB in the same vessel
- Patients with glomerular filtration rate \<30 ml/min/ 1.73 m2
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Spain
- Gijón, Spain
- Huelva, Spain
- León, Spain
- Lugo, Spain
- Oviedo, Spain
- Pontevedra, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Spain; Gijón, Spain; Huelva, Spain; León, Spain; Lugo, Spain; Oviedo, Spain and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.