Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)

University National Heart Hospital1 site in 1 country106 target enrollmentOctober 1, 2022

ConditionsCoronary Artery Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Coronary Artery Disease
Sponsor: University National Heart Hospital
Enrollment: 106
Locations: 1
Primary Endpoint: Major Adverse Cardiovascular Events (MACE)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is a prospective, single-center, single-arm study to evaluate the feasibility and safety of the combination of Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the treatment of diffuse, small vessel coronary artery disease. The objective of the study is to demonstrate the feasibility and safety of the combination of scoring-balloon angioplasty (SBA) plus sirolimus-eluting balloon angioplasty (SEBA) for diffuse (lesion length ≥20 mm), small vessel (diameter 1.5 mm -2.75 mm) coronary disease.

Registry

clinicaltrials.gov

Start Date

October 1, 2022

End Date

December 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

University National Heart Hospital

Responsible Party

Principal Investigator

Dobrin Vassilev

Professor

Medica Cor Heart Hospital

Eligibility Criteria

Inclusion Criteria

•Patientsaged≥18years.
•Presence of epicardial coronary artery disease with lesion length ≥ 20 mm and vessel diameter less than 2.75 mm and more than 1.5 mm with diameter stenosis \>50% by visual evaluation.

Exclusion Criteria

•Life expectancy \< 2 years
•Left ventricular EF ≤40%
•Pregnantorlactatingfemales.
•Moderate and moderate-to-severe valvular heart disease.
•Hemodynamic instability.
•Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
•Patients with hypersensitivity or allergies to aspirin, heparin, clopidogrel, ticlopidine, bivalirudin, prasugrel, ticagrelor and drug such as Sirolimus (Rapamycin) or similar drugs or any analogue or derivative, hydrogenated castor oil, PVP or any contrast media.
•Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.
•Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
•Transplant patients.

Outcomes

Primary Outcomes

Major Adverse Cardiovascular Events (MACE)

Time Frame: 12 months

Composite of non-fatal MI, cardiovascular death, and target lesion revascularization

Secondary Outcomes

Target Vessel Failure (TVF)(3 months, 6 months, 12 months, 24 months, 36 months)
Cardiovascular Death(3 months, 6 months, 12 months, 24 months, 36 months)
Target Lesion Revascularization (TLR)(3 months, 6 months, 12 months, 24 months, 36 months)
Non-fatal Myocardial Infarction(3 months, 6 months, 12 months, 24 months, 36 months)
Restenosis(3 months)
Major bleeding(3 months, 6 months, 12 months, 2 years and 3 years)
Quality of Life Score(Baseline, 3 months, 6 months, 12 months)
Device success(During the procedure)