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New treatment option for Coronary Artery Disease
Official title MagicTouch™Sirolimus-Coated Balloon for Treatment of Coronary Artery Lesions in Small Vessels
ClinicalTrials.gov ID: NCT06271590
What this study is testing
- What it's testing
- This is a multicenter, randomized, single-blind pivotal study to evaluate the safety and efficacy of the MagicTouchTM Drug coated balloon in treatment of small vessels in patients with coronary artery disease. The objective is to establish the safety and efficacy of the Magic TouchTM Drug coated balloon in treatment of small vessels (≤2.75 mm).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- Clinical
- Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually...
- Subject is ≥18 and \<80 years old
- Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent Angiographic
- Target reference vessel diameter (visual estimation) ≤2.75 mm
You likely can't join if
- Planned (staged) intervention in the target vessel
- ST-segment-elevation MI within 48 hours prior to index procedure
- people with acute cardiac decompensation or cardiogenic shock
- Subject with a life expectancy of less than 24 months
- Impaired renal function (glomerular filtration rate [GFR] \<30 mL/min)
- Documented left ventricular ejection fraction (LVEF) ≤30%
See the full eligibility criteria
- Clinical
- Adult patient with an indication for PCI due to stable angina, NSTEACS, post-infarction angina or silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive...
- Subject is ≥18 and \<80 years old
- Subject is willing to comply with all protocol-required follow-up evaluations and provides written informed consent Angiographic
- Target reference vessel diameter (visual estimation) ≤2.75 mm
- Successful lesion preparation (residual stenosis \<30%), without flow-limiting complications (no or slow flow, dissection etc.)
- Target lesion(s) in a native coronary artery
- Up to two small vessel target lesions in two different vessels
- Target lesion length (visual estimation): ≥6.0 and ≤34.0 mm and can be covered by a single 40 mm balloon
- Target lesion diameter stenosis (visual estimation) \>30% and \<100% with Thrombolysis in Myocardial Infarction (TIMI) flow grade ≥2 Clinical
- Planned (staged) intervention in the target vessel
- ST-segment-elevation MI within 48 hours prior to index procedure
- people with acute cardiac decompensation or cardiogenic shock
- Subject with a life expectancy of less than 24 months
- Impaired renal function (glomerular filtration rate [GFR] \<30 mL/min)
- Documented left ventricular ejection fraction (LVEF) ≤30%
- Known allergies to acetylsalicylic acid, clopidogrel, prasugrel, ticagrelor, heparin, contrast medium, sirolimus or similar drugs (i.e., ABT-578 [Zotarolimus], biolimus, tacrolimus)
- Relative or absolute contraindication to dual antiplatelet therapy (DAPT) for at least 1 month (e.g., planned surgeries that cannot be delayed)
- Subject has an indication for chronic oral anticoagulation treatment and a contraindication for concomitant treatment with a P2Y12 inhibitor
- If femoral access is planned, significant peripheral arterial disease which precludes safe insertion of a 6F sheath
- Hemoglobin \<9 g/dL
- Platelet count \ 700,000 cells/mm3
- White blood cell count \<3,000 cells/mm3
- Active infection undergoing treatment
- Clinically significant liver disease
- Cerebrovascular accident (CVA) within 3 months or has any permanent neurological defect as a result of CVA
- Subject is receiving oral or intravenous immunosuppressive therapy (e.g., inhaledsteroids are not excluded) or has known life-limiting immunosuppressive or autoimmune disease (e.g., human immunodeficiency virus...
- Subject is unlikely to comply with the follow up requirements, per investigator's assessment
- Subject currently enrolled in other investigational device or drug trial in which primary endpoint has not been reached
- Pregnant and/or breast-feeding females or females who intend to become pregnant during the time of the study Angiographic Exclusion Criteria: All exclusion criteria apply to the target lesion(s) or target vessel(s)
- Re-stenotic lesion(s), whether due to percutaneous old balloon angioplasty (POBA) or prior stenting
- True bifurcation lesion (lesion involves both main and side branch\>2.5 mm) with planned treatment of both branches per investigator assessment
- Angiographic evidence of thrombus in the target vessel
- Myocardial bridging
- Target lesion is heavily calcified
- Diffuse distal disease to target lesion with impaired runoff, TIMI flow \<2
- Non-target lesion in the target vessel requiring PCI Note: Non-target vessel PCI is allowed at the time of index procedure if performed prior to study intervention and if successful and uncomplicated. For target lesions...
The study team makes the final eligibility decision.
Where it's taking place
- Gilbert, Arizona, United States
- Los Angeles, California, United States
- Clearwater, Florida, United States
- Jacksonville, Florida, United States
- Tallahassee, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Decatur, Georgia, United States
- Maywood, Illinois, United States
- Tupelo, Mississippi, United States
- Pomona, New Jersey, United States
- Brooklyn, New York, United States
- Manhasset, New York, United States
- New York, New York, United States
- The Bronx, New York, United States
- Raleigh, North Carolina, United States
- Cleveland, Ohio, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Pittsburgh, Pennsylvania, United States
+ 2 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Gilbert, Arizona, United States; Los Angeles, California, United States; Clearwater, Florida, United States; Jacksonville, Florida, United States; Tallahassee, Florida, United States; Tampa, Florida, United States and 16 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.