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)

Coronary Artery Disease Clinical Trial

Official title:

DRUG RELEASING BALL vs. PHARMACOACTIVE STENT IN LARGE VESSELS: MORPHOLOGICAL ANALYSIS AND FUNCTION VASOMOTOR (DEBORA STUDY)

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06448637
• Other study ID #: EPIC37-DEBORA
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 30, 2024
• Est. completion date: May 1, 2027

Study information

• Verified date: June 2024
• Source: Fundación EPIC
• Contact: IÑIGO LOZANO MARTINEZ-LUENGAS, MD, PhD
• Phone: 0034630901145
• Email: inigo.lozano[@]fundacionepic.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 94
• Est. completion date: May 1, 2027
• Est. primary completion date: May 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Coronary Artery Disease

Intervention

Device:
• Drug Coated Balloon (DCB)
Drug Coated Balloon (DCB) in patients with indication of Percutaneous Coronary Intervention (PCI)
• Drug Eluting Stent (DES)
Drug Eluting Stent (DES) in patients with indication of Percutaneous Coronary Intervention (PCI)

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Fundación EPIC

References & Publications (5)

Brugaletta S, Heo JH, Garcia-Garcia HM, Farooq V, van Geuns RJ, de Bruyne B, Dudek D, Smits PC, Koolen J, McClean D, Dorange C, Veldhof S, Rapoza R, Onuma Y, Bruining N, Ormiston JA, Serruys PW. Endothelial-dependent vasomotion in a coronary segment treated by ABSORB everolimus-eluting bioresorbable vascular scaffold system is related to plaque composition at the time of bioresorption of the polymer: indirect finding of vascular reparative therapy? Eur Heart J. 2012 Jun;33(11):1325-33. doi: 10.1093/eurheartj/ehr466. Epub 2012 Apr 16. — View Citation

Gomez-Lara J, Oyarzabal L, Ortega-Paz L, Brugaletta S, Romaguera R, Salvatella N, Roura G, Rivero F, Fuentes L, Alfonso F, Otaegui I, Vandeloo B, Vaquerizo B, Sabate M, Comin-Colet J, Gomez-Hospital JA. Coronary Endothelium-Dependent Vasomotor Function After Drug-Eluting Stent and Bioresorbable Scaffold Implantation. J Am Heart Assoc. 2021 Nov 16;10(22):e022123. doi: 10.1161/JAHA.121.022123. Epub 2021 Nov 3. — View Citation

Gutierrez E G-LJ, Escaned J, Cruz I, Ojeda S, Romaguera R, Moreno R. Valoración de la función endotelial y provocación de vasoespasmo coronario mediante infusión intracoronaria de acetilcolina. Documento técnico de la ACI-SEC. REC Interv Cardiol. 2021;3(4):286-296.

Nakamura T, Brott BC, Brants I, Panchal D, Li J, Chen JP, King SB 3rd, Chronos N, Hou D. Vasomotor function after paclitaxel-coated balloon post-dilation in porcine coronary stent model. JACC Cardiovasc Interv. 2011 Feb;4(2):247-55. doi: 10.1016/j.jcin.2010.08.028. — View Citation

Yerasi C, Case BC, Forrestal BJ, Torguson R, Weintraub WS, Garcia-Garcia HM, Waksman R. Drug-Coated Balloon for De Novo Coronary Artery Disease: JACC State-of-the-Art Review. J Am Coll Cardiol. 2020 Mar 10;75(9):1061-1073. doi: 10.1016/j.jacc.2019.12.046. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the preservation of vasomotor function dependent on the endothelium in the segment distal to the culprit lesion	Preservation of vasomotor function dependent on the endothelium by acetyl-coline test	8 months
Secondary	Comparison of percentage of angiographic restenosis by quantitative coronary	Comparison of percentage of angiographic restenosis by quantitative coronary	8 months
Secondary	Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography	Comparison of the minimum luminal diameter of the treated segment by optical coronary tomography	8 months
Secondary	Comparison of the minimum luminal area of the treated segment by optical coronary tomography	Comparison of the minimum luminal area of the treated segment by optical coronary tomography	8 months
Secondary	Percentage of of strut coverage by OCT(Optical Coherence Tomography) in the DES group	Percentage of of strut coverage by OCT in the DES group	8 months
Secondary	To determine normal vessel architecture with correct definition of intima and media by OCT in the DCB group intima and media by OCT in the DCB group	To determine normal vessel architecture with correct definition of intima and media by OCT in the DCB group	8 months