Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
NCT ID: NCT06197022
Last Updated: 2024-01-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
106 participants
INTERVENTIONAL
2022-10-01
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of Sirolimus-coated Coronary Balloon Dilatation Catheter for Coronary Small Vessels
NCT06345209
MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
NCT06271590
TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon
NCT03913832
The Clinical Efficacy and Safety of Drug-coated Balloon
NCT05133921
Safety and Efficacy of Drug-Coated Balloon for De-novo Lesions in Patients With Acute Coronary Syndromes (DCB-ACS)
NCT04937803
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Scoring Balloon Angioplasty
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.
Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. 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
2. Left ventricular EF ≤40%
3. Pregnantorlactatingfemales.
4. Moderate and moderate-to-severe valvular heart disease.
5. Hemodynamic instability.
6. Severe renal dysfunction, defined as an eGFR \<30 mL/min/1.73 m2
7. 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.
8. Patients in whom anti-platelet and/or anti-coagulant therapy are contraindicated.
9. Patients judged to have a lesion that prevents complete inflation of an angioplasty balloon.
10. Transplant patients.
11. Patients with calcified lesion requiring other type of treatment such as Rotational Atherectomy.
12. Unprotected left main coronary artery lesions
13. Coronary artery spasm in the absence of a significant stenosis.
14. Patients whose diseased segment cannot be pre-dilated or prepared before drug coated balloon treatment.
18 Years
95 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Meril Life Sciences Pvt. Ltd.
INDUSTRY
University National Heart Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dobrin Vassilev
Professor
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Medica Core Heart Hopsital
Rousse, , Bulgaria
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SCA-DEB_2022
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.