- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03913832
TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon (TRANSFORM I)
Magic Touch Sirolimus Coated Balloon (Concept Medical) Versus SeQuent Pease Neo Paclitaxel Coated Balloon (Bbraun) for the Treatment of de Novo Coronary Artery Lesions in Small Vessels
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Galway, Ireland
- Galway University Hospital
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Rozzano, Italy
- Istituto Clinico Humanitas
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Emilia-Romagna
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Cotignola, Emilia-Romagna, Italy, 48033
- Maria Cecilia Hospital SPA
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Lombardy
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San Donato Milanese, Lombardy, Italy, 20097
- I.R.C.C.S. Policlinico San Donato
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Tuscany
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Firenze, Tuscany, Italy, 50134
- AOUC Azienda Ospedaliero-Universitaria Careggi
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Birmingham, United Kingdom
- Heart of England NHS Trust, Heartlands Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male or female patients ≥18 years
Patient with chronic stable angina or stabilized acute coronary syndromes with normal cardiac biomarker values
Note: For patients showing elevated Troponin (e.g. non-STEMI patients) at baseline (within 72h pre-PCI) an additional blood sample must be collected prior to randomization to confirm that:
- hs-cTn or Troponin I or T levels are stable, i.e. the value should be within 20% range of the value found in the first sample at baseline, or have dropped
- CK-MB and CK levels are within normal range If hs-cTn or Troponin I or T levels are stable or have dropped, the CK-MB and CK levels are within normal ranges, and the ECG is normal, the patient may be included in the study.
- The patient has a planned intervention in one or two separate major epicardial territories (LAD, LCX or RCA) and has at least one de-novo lesion in a small vessel (≤2.75mm by QCA prior to pre-dilatation)
- Target lesion length ≤30 mm
- Able to understand and provide informed consent and comply with all study procedures including 6 months angiographic follow-up
- Patient must have completed the follow-up phase of any previous study
Exclusion Criteria:
- Patient is a woman who is pregnant or nursing (a pregnancy test must be performed within 7 days prior to the index procedure in women of child-bearing potential)
- Evidence of ongoing acute myocardial infarction (AMI) in ECG and/or elevated cardiac biomarkers (according to local standard hospital practice) have not returned within normal limits at the time of procedure
- Known contraindication or hypersensitivity to sirolimus, paclitaxel, or to medications such as aspirin, heparin, and all of the following four medications: clopidogrel bisulfate, ticlopidine, prasugrel, ticagrelor
- Patient suffered from stroke/TIA during the last 6 months
- LVEF <30%
- Platelet count <100,000 cells/mm3 or >400,000 cells/mm3, a WBC of <3,000 cells/mm3, or documented or suspected liver disease (including laboratory evidence of hepatitis)
- Known renal insufficiency (e.g. serum creatinine >2.5mg/dL, or creatinine clearance ≤30 mL/min), or subject on dialysis, or acute kidney failure (as per physician judgment)
- Patient undergoing planned surgery within 6 months with the necessity to stop DAPT
- History of bleeding diathesis or coagulopathy
- The patient is a recipient of a heart transplant
- Concurrent medical condition with a life expectancy of less than 12 months
- The patient is unwilling/not able to return for angiographic recatherisation at 6 month follow-up
Currently participating in another trial and not yet at its primary endpoint.
Angiographic exclusion criteria:
- The patient has a planned intervention in three separate major epicardial territories (3 vessel disease)
- The patient has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel disease)
- Target vessel size >2.75 mm (by QCA)
- Target vessel size <2.00 mm (by QCA)
- Target lesion has a total occlusion or TIMI flow <2
- Target lesion in left main stem
- The target vessel contains visible thrombus
- Aorto-ostial target lesion (within 3 mm of the aorta junction)
- Moderate-severe tortuous, calcified or angulated coronary anatomy of the target vessel that in the opinion of the investigator would result in suboptimal imaging or excessive risk of complication from placement of an OCT catheter
- Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: sirolimus drug coated balloon (SCB)
Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)
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Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB) for PCI, based on a polymer-free and Nano based drug delivery technology.
Magic Touch SCB is a product of CMI proprietary drug delivery technology "Nanolute".
It is indicated (CE approved) for ISR, small vessels, bifurcation lesions & de novo lesions.
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Active Comparator: paclitaxel releasing coronary balloon catheter.
SeQuent PleaseTM (B.
Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter
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SeQuent PleaseTM (B.
Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Net Gain (mm) In-segment
Time Frame: 6 Months
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The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.
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6 Months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Device success
Time Frame: Post procedure (Right after the treatment with drug coated balloon)
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Successful delivery and inflation within 45 seconds of the allocated DCB device at the intended target lesion during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30% (by Quantitative Coronary angiography).
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Post procedure (Right after the treatment with drug coated balloon)
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Procedure Success
Time Frame: Post procedure (Right after the treatment with drug coated balloon)
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Successful delivery and inflation within 45 seconds of the allocated DCB device at all intended target lesion(s) during an attempt with a DCB not previously used (first use) and successful withdrawal of the device system with attainment of final in-lesion residual stenosis of <30% (by QCA) without the occurrence of TLF during the index procedure hospital stay).
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Post procedure (Right after the treatment with drug coated balloon)
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Acute/subacute/early/late vessel closure/thrombosis
Time Frame: 1, 6 months and 12 Months
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Closure by restenosis or thrombosis (diameter stenosis of 100% and/or TIMI grade 0).
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1, 6 months and 12 Months
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Angiographic outcomes: late lumen loss
Time Frame: 6 months
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The difference between the minimum lumen diameter (MLD) immediately after index procedure and the MLD at follow-up as measured in (preferable) identical orthogonal views (MLDpost - MLDfup).
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6 months
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Angiographic outcomes:Minimal lumen diameter
Time Frame: 6 months
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The smallest lumen diameter in the segment of interest
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6 months
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Angiographic outcomes: Percent diameter stenosis
Time Frame: 6 months
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The percentage of luminal narrowing of vessel segment of interest
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6 months
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Angiographic outcomes: Restenosis rate
Time Frame: 6 months
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Restenosis is defined as ≥50% diameter stenosis at follow-up.
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6 months
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Device oriented Composite Endpoint (DoCE / TLF): Cardiac death
Time Frame: 1, 6 months and 12 Months
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Any death due to proximate cardiac cause (e.g.
MI, low-output failure, fatal arrhythmia), unwitnessed death and death of unknown cause, all study procedure related deaths including those related to concomitant treatment.
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1, 6 months and 12 Months
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Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI)
Time Frame: 1, 6 months and 12 Months
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The term myocardial injury should be used when there is evidence of elevated cardiac troponin values (cTn) with at least one value above the 99th percentile upper reference limit (URL) TV-MI: Myocardial Infarction not clearly attributable to a non-target vessel.
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1, 6 months and 12 Months
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Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR)
Time Frame: 1, 6 months and 12 Months
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TLR is defined as any repeat percutaneous intervention of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
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1, 6 months and 12 Months
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Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Patrick Serruys, Dr, NUIG Imaging CoreLab
- Study Chair: Bernardo Cortese, Dr, Fondazione RIC
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Myocardial Ischemia
- Heart Diseases
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Coronary Disease
- Coronary Artery Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Anti-Bacterial Agents
- Antibiotics, Antineoplastic
- Antifungal Agents
- Paclitaxel
- Sirolimus
Other Study ID Numbers
- 180013
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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