Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Phase 4NCT07326735
MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
A Phase 4 study testing Mamba Sirolimus-Eluting PTCA Balloon and Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Frisch Medical Device Private Limited at 2 sites in 2 countries.
Trial summary
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))
- What is being tested?
- Mamba Sirolimus-Eluting PTCA Balloon and Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 11 Jan 2023to 3 Mar 2024
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 18 years or older.
- Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention.
- Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm.
- Successful lesion preparation prior to DCB treatment (defined by <30% residual stenosis and TIMI flow ≥2).
- Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months.
- Signed informed consent obtained prior to the procedure.
Who cannot join
- ST-elevation myocardial infarction (STEMI) within the previous 48 hours.
- Left main disease >50% requiring stenting or surgical intervention.
- Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion.
- Previous stenting at the target lesion within the previous 3 months.
- Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy.
- Pregnant or breastfeeding women.
- Life expectan
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. It includes analysis of clinical data from the MIRAGE clinical study, literature data on sirolimus DCBs, bench and preclinical testing, and risk-benefit evaluation in compliance with MDR Annex XIV.
Read the detailed description
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. It includes analysis of clinical data from the MIRAGE clinical study, literature data on sirolimus DCBs, bench and preclinical testing, and risk-benefit evaluation in compliance with MDR Annex XIV.
- Being tested
- Mamba Sirolimus-Eluting PTCA Balloon, Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon
- Keywords
- Drug Coated balloons, DCB , DEB, Sirolimus, de novo , in-stent restenosis lesions
- Medical subject headings
- Coronary Artery Disease, Angina Pectoris, Myocardial Infarction, Color Vision Defects
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mamba Sirolimus-Eluting PTCA BalloonDevice
PTCA coronary angioplasty with Drug coated balloon for De novo and in stent restenosis cases
Percutaneous Coronary Angioplasty with Sirolimus-Coated BalloonDevice
Percutaneous transluminal coronary angioplasty performed using a sirolimus-coated balloon catheter intended to deliver the drug to the arterial wall during balloon inflation. The balloon is positioned across the target lesion following standard lesion preparation and inflated for approximately 30-45 seconds; multiple inflations are permitted. No permanent implant or scaffold remains in the artery. The sirolimus coating is designed to inhibit neointimal hyperplasia and support vessel healing, offering a "leave-nothing-behind" approach to treatment of obstructive coronary artery disease.
| Study group | Role | What they receive |
|---|---|---|
| Mamba Sirolimus Drug-Coated Balloon (DCB) | Experimental | Participants undergo percutaneous coronary angioplasty using the Mamba Sirolimus Drug-Coated Balloon (DCB) following standard lesion preparation. Balloon is inflated 30-45 seconds; multiple inflations permitted. No implant is left behind. Receives: Device: Mamba Sirolimus-Eluting PTCA Balloon; Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization
MACE is defined as the composite rate of cardiac death, myocardial infarction, or clinically driven target lesion revascularization occurring within 12 months following the index procedure.
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2026
- Study start11 Jan 2023
- Primary completion22 Jan 2024
- Study completion3 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD))Studies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Drug coted coronary PTCA balloons
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Frisch Medical Device Private Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bhavin Oza, Study chair, Frisch Medical Devices
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07326735
- Sponsor's protocol ID
- MIRAGE-DCB-2023-01
- Other IDs
- MIRAGE-DCB-2023-01
- Status last verified
- Mar 2026
- First submitted
- 10 Dec 2025
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MIRAGE Study: Clinical Outcomes of the Mamba Sirolimus-Eluting PTCA Balloon
- ClinicalTrials.gov ID
- NCT07326735
- Acronym / sponsor ID
- MIRAGE-DCB-2023-01
- Keywords
- Drug Coated balloons, DCB , DEB, Sirolimus, de novo , in-stent restenosis lesions
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Frisch Medical Device Private LimitedIndustry (pharma, biotech, devices)
- Study start
- 11 Jan 2023 (actual)
- Primary completion
- 22 Jan 2024 (actual)
- Study completion
- 3 Mar 2024 (actual)
- First posted
- 8 Jan 2026 (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 Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. It includes analysis of clinical data from the MIRAGE clinical study, literature data on sirolimus DCBs, bench and preclinical testing, and risk-benefit evaluation in compliance with MDR Annex XIV.
Detailed description
This Clinical Evaluation Report (CER) covers the Mamba Sirolimus-Eluting PTCA Balloon catheter intended for the treatment of coronary artery disease in de novo or in-stent restenosis lesions. It includes analysis of clinical data from the MIRAGE clinical study, literature data on sirolimus DCBs, bench and preclinical testing, and risk-benefit evaluation in compliance with MDR Annex XIV.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Drug coted coronary PTCA balloons
| Arm | Type | Receives |
|---|---|---|
| Mamba Sirolimus Drug-Coated Balloon (DCB) | Experimental | Device: Mamba Sirolimus-Eluting PTCA Balloon, Device: Percutaneous Coronary Angioplasty with Sirolimus-Coated BalloonParticipants undergo percutaneous coronary angioplasty using the Mamba Sirolimus Drug-Coated Balloon (DCB) following standard lesion preparation. Balloon is inflated 30-45 seconds; multiple inflations permitted. No implant is left behind. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years or older.
- Patient diagnosed with obstructive coronary artery disease suitable for percutaneous coronary intervention.
- Target lesion located in a native coronary artery with reference vessel diameter of ≥2.0 mm.
- Successful lesion preparation prior to DCB treatment (defined by <30% residual stenosis and TIMI flow ≥2).
- Patient able and willing to comply with scheduled follow-up evaluations at 1, 6, and 12 months.
Key exclusion criteria (7 listed)
- ST-elevation myocardial infarction (STEMI) within the previous 48 hours.
- Left main disease >50% requiring stenting or surgical intervention.
- Presence of thrombus or severe vessel calcification that prevents adequate balloon expansion.
- Previous stenting at the target lesion within the previous 3 months.
- Known allergy or contraindication to sirolimus, contrast media, or dual antiplatelet therapy.
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 |
|---|---|---|
| Mamba Sirolimus-Eluting PTCA BalloonPTCA coronary angioplasty with Drug coated balloon for De novo and in stent restenosis cases | Device | Mamba Sirolimus Drug-Coated Balloon (DCB) |
| Percutaneous Coronary Angioplasty with Sirolimus-Coated BalloonPercutaneous transluminal coronary angioplasty performed using a sirolimus-coated balloon catheter intended to deliver the drug to the arterial wall during balloon inflation. The balloon is positioned across the target lesion following standard lesion preparation and inflated for approximately 30-45 seconds; multiple inflations are permitted. No permanent implant or scaffold remains in the artery. The sirolimus coating is designed to inhibit neointimal hyperplasia and support vessel healing, offering a "leave-nothing-behind" approach to treatment of obstructive coronary artery disease. | Device | Mamba Sirolimus Drug-Coated Balloon (DCB) |
Primary outcome
Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization
Time frame: 12 Months
MACE is defined as the composite rate of cardiac death, myocardial infarction, or clinically driven target lesion revascularization occurring within 12 months following the index procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- 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.
Bhavin Oza study chair
Frisch Medical Devices
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Mamba Sirolimus-Eluting PTCA Balloon and Percutaneous Coronary Angioplasty with Sirolimus-Coated Balloon in people with Coronary Artery Disease (CAD) (E.G., Angina, Myocardial Infarction, and Atherosclerotic Heart Disease (ASHD)), run by Frisch Medical Device Private Limited at 2 sites in 2 countries.
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 6 inclusion and 7 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: finished, as of the sponsor's last update on 11 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Burma, Malaysia. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Composite Measure of Major Adverse Cardiac Events (MACE) at 12 Months including Cardiac Death, Myocardial Infarction, and Clinically Driven Target Lesion Revascularization (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 11 Mar 2026.