Coronary Artery DiseaseSCA-DEBNCT06197022
Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
A study testing Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in people with Coronary Artery Disease, run by University National Heart Hospital at 1 site in Bulgaria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 95 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 106 participants
- Where
- 1 siteBulgaria
- Study dates
- 1 Oct 2022to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 95 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
Bulgaria1 site, 1 recruiting
- Recruiting
Medica Core Heart Hopsital
Rousse, 7000
Dobrin Vassilev, MD, PhD, 00359886846550, dobrinv@mail.comg
About this study
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
- Being tested
- Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation CatheterDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events (MACE)
Composite of non-fatal MI, cardiovascular death, and target lesion revascularization
Measured: 12 months
Secondary outcomes (8)
Cardiovascular Death
Defined as per Academic Research Consortium-2 (ARC-2) criteria
Measured: 3 months, 6 months, 12 months, 24 months, 36 months
Non-fatal Myocardial Infarction
Non-fatal myocardial infarction (MI) is defined as per the fourth universal definition of MI
Measured: 3 months, 6 months, 12 months, 24 months, 36 months
Target Lesion Revascularization (TLR)
It is defined as repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion
Measured: 3 months, 6 months, 12 months, 24 months, 36 months
Target Vessel Failure (TVF)
It is defined as the composite of cardiovascular death, target vessel myocardial infarction and target vessel revascularization
Measured: 3 months, 6 months, 12 months, 24 months, 36 months
Restenosis
Defined as >50% stenosis at the treated segment.
Measured: 3 months
Major bleeding
Defined as bleeding that causes hemodynamic instability and/or leads to blood transfusion
Measured: 3 months, 6 months, 12 months, 2 years and 3 years
Quality of Life Score
OverallHealthStatusassessedbyShortFormSurvey(SF-12)
Measured: Baseline, 3 months, 6 months, 12 months
Device success
Defined as the ability of the study device to be delivered, dilated, and retrieved from the target lesion
Measured: During the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2024
- Study start1 Oct 2022
- Primary completionOct 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University National Heart Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd.
- Responsible party
- Principal investigator, Dobrin Vassilev, Medica Cor Heart Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06197022
- Sponsor's protocol ID
- SCA-DEB_2022
- Acronym
- SCA-DEB
- Status last verified
- Dec 2023
- First submitted
- 25 Dec 2023
- Last updated
- 9 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Scoring-Balloon Angioplasty and Sirolimus-Eluting Balloon Angioplasty for the Treatment of Diffuse, Small Vessel Coronary Artery Disease (SCA-DEB Study)
- ClinicalTrials.gov ID
- NCT06197022
- Acronym / sponsor ID
- SCA-DEB / SCA-DEB_2022
- Conditions
- Coronary Artery Disease
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- University National Heart HospitalUniversity, hospital or other
- Collaborators
- Meril Life Sciences Pvt. Ltd.
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 9 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Scoring Balloon Angioplasty | Other | Device: Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation CatheterCombination 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. |
Who may qualify
- Ages
- 18 to 95 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (14 listed)
- Life expectancy < 2 years
- Left ventricular EF ≤40%
- Pregnantorlactatingfemales.
- Moderate and moderate-to-severe valvular heart disease.
- Hemodynamic instability.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation CatheterCombination 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 | Scoring Balloon Angioplasty |
Primary outcome
Major Adverse Cardiovascular Events (MACE)
Time frame: 12 months
Composite of non-fatal MI, cardiovascular death, and target lesion revascularization
8 secondary outcomes
Cardiovascular Death
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months
Non-fatal Myocardial Infarction
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months
Target Lesion Revascularization (TLR)
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months
Target Vessel Failure (TVF)
Time frame: 3 months, 6 months, 12 months, 24 months, 36 months
Restenosis
Time frame: 3 months
Major bleeding
Time frame: 3 months, 6 months, 12 months, 2 years and 3 years
Quality of Life Score
Time frame: Baseline, 3 months, 6 months, 12 months
Device success
Time frame: During the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mozec™ SEB Sirolimus Eluting Rx PTCA Balloon Dilatation Catheter in people with Coronary Artery Disease, run by University National Heart Hospital at 1 site in Bulgaria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bulgaria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dobrin Vassilev, MD, PhD (+3590886846550, dobrinv@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular Events (MACE) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2024.