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

NCT06197022 | Unknown

• 1 other identifier: SCA-DEB_2022
• Study Type: interventional
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Major Adverse Cardiovascular Events (MACE)

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

  12 months

Secondary Outcomes (8)

• Cardiovascular Death

  3 months, 6 months, 12 months, 24 months, 36 months

• Non-fatal Myocardial Infarction

  3 months, 6 months, 12 months, 24 months, 36 months

• Target Lesion Revascularization (TLR)

  3 months, 6 months, 12 months, 24 months, 36 months

• Target Vessel Failure (TVF)

  3 months, 6 months, 12 months, 24 months, 36 months

• Restenosis

  3 months

Study Arms (1)

Scoring Balloon Angioplasty

OTHER

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.

Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter

Interventions

Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter DEVICE

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.

Scoring Balloon Angioplasty

Eligibility Criteria

• Age: 18 Years - 95 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University National Heart Hospital: lead
• Meril Life Sciences Pvt. Ltd.: collaborator

Study Sites (1)

Medica Core Heart Hopsital

Rousse, 7000, Bulgaria

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Central Study Contacts

Dobrin Vassilev, MD, PhD

CONTACT

+3590886846550; dobrinv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 25, 2023
• First Posted: January 9, 2024
• Study Start: October 1, 2022
• Primary Completion: October 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 9, 2024

Record last verified: 2023-12

Locations

BU (1)