Status:
UNKNOWN
Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
Lead Sponsor:
University National Heart Hospital
Collaborating Sponsors:
Meril Life Sciences Pvt. Ltd.
Conditions:
Coronary Artery Disease
Eligibility:
All Genders
18-95 years
Phase:
NA
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 treatm...
Eligibility Criteria
Inclusion
- 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
- 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.
- Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
- Unprotected left main coronary artery lesions
- Coronary artery spasm in the absence of a significant stenosis.
- Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
Key Trial Info
Start Date :
October 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT06197022
Start Date
October 1 2022
End Date
December 1 2024
Last Update
January 9 2024
Active Locations (1)
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1
Medica Core Heart Hopsital
Rousse, Bulgaria, 7000