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)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

94 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-23

Study Completion Date

2027-05-01

Brief Summary

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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

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Detailed Description

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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

Conditions

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Coronary Artery Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Drug Coated Balloon (DCB)

Group Type ACTIVE_COMPARATOR

Drug Coated Balloon (DCB)

Intervention Type DEVICE

Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)

Drug Eluting Stent (DES)

Group Type EXPERIMENTAL

Drug Eluting Stent (DES)

Intervention Type DEVICE

Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

Interventions

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Drug Coated Balloon (DCB)

Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)

Intervention Type DEVICE

Drug Eluting Stent (DES)

Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

Intervention Type DEVICE

Eligibility Criteria

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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).
* 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No