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TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon (TRANSFORM I)

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ClinicalTrials.gov Identifier: NCT03913832
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : March 9, 2022
Sponsor:
Information provided by (Responsible Party):
Concept Medicals BV

Study Description
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Brief Summary:
The study is a prospective, multinational (Italy and UK), multicenter, randomised Clinical Trial that compares the efficacy and performance of two drug coated balloon (DCB), the MAGIC TOUCH sirolimus coated balloon (Concept Medical) and SeQuent Please paclitaxel coated balloon (B Braun). The objective of the study is to compare angiographic outcomes of Magic TouchTM sirolimus coated balloon (Concept Medical) versus SeQuentTM paclitaxel coated balloon (Bbraun) for the treatment of de novo coronary artery lesions in small vessels (≤2.5 mm) with respect to Net Gain (mm) at 6 months follow-up

Condition or disease Intervention/treatment Phase
Coronary Artery Disease DCB Device: sirolimus drug coated balloon (SCB) Device: paclitaxel releasing coronary balloon catheter Not Applicable

Detailed Description:
A prospective, randomized, multi-centre study in subjects with small vessels, i.e. at least one de-novo lesion in a small vessel (≤2.5mm). Vessel size will be determined first by QCA on-line (screening, pre-procedure). If, based on QCA on-line the vessel size pre-procedure is ≤2.5mm and following a successful pre-dilatation (i.e. no angiographic dissections type CDEF and TIMI>2), the subject will be randomized in a 1:1 fashion to Magic Touch or SeQuent Please Neo. OCT will be performed post pre-dilatation (guidance) prior to drug coated balloon (DCB) treatment. The DCB balloon size will be selected based on OCT measurements.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 114 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : August 28, 2020
Estimated Primary Completion Date : May 2022
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: sirolimus drug coated balloon (SCB)
Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)
 Device: sirolimus drug coated balloon (SCB)
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.
Active Comparator: paclitaxel releasing coronary balloon catheter.
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter
 Device: paclitaxel releasing coronary balloon catheter
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.


Outcome Measures
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Primary Outcome Measures :
  1. Net Gain (mm) In-segment [ Time Frame: 6 Months ]
    The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.


Secondary Outcome Measures :
  1. Device success [ Time Frame: Post procedure (Right after the treatment with drug coated balloon) ]
    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).

  2. Procedure Success [ Time Frame: Post procedure (Right after the treatment with drug coated balloon) ]
    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).

  3. Acute/subacute/early/late vessel closure/thrombosis [ Time Frame: 1, 6 months and 12 Months ]
    Closure by restenosis or thrombosis (diameter stenosis of 100% and/or TIMI grade 0).

  4. Angiographic outcomes: late lumen loss [ Time Frame: 6 months ]
    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).

  5. Angiographic outcomes:Minimal lumen diameter [ Time Frame: 6 months ]
    The smallest lumen diameter in the segment of interest

  6. Angiographic outcomes: Percent diameter stenosis [ Time Frame: 6 months ]
    The percentage of luminal narrowing of vessel segment of interest

  7. Angiographic outcomes: Restenosis rate [ Time Frame: 6 months ]
    Restenosis is defined as ≥50% diameter stenosis at follow-up.

  8. Device oriented Composite Endpoint (DoCE / TLF): Cardiac death [ Time Frame: 1, 6 months and 12 Months ]
    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.

  9. Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI) [ Time Frame: 1, 6 months and 12 Months ]
    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.

  10. Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR) [ Time Frame: 1, 6 months and 12 Months ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female patients ≥18 years

  2. 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.
  3. 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 (≤2.5mm by QCA prior to pre-dilatation)
  4. Target lesion reference diameter ≤2.50 mm as assessed by OCT (post pre-dilatation)
  5. Target lesion length ≤30 mm
  6. Able to understand and provide informed consent and comply with all study procedures including 6 months angiographic follow-up
  7. Patient must have completed the follow-up phase of any previous study

Exclusion Criteria:

  1. 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)
  2. 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
  3. 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
  4. Patient suffered from stroke/TIA during the last 6 months
  5. LVEF <30%
  6. 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)
  7. 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)
  8. Patient undergoing planned surgery within 6 months with the necessity to stop DAPT
  9. History of bleeding diathesis or coagulopathy
  10. The patient is a recipient of a heart transplant
  11. Concurrent medical condition with a life expectancy of less than 12 months
  12. The patient is unwilling/not able to return for angiographic recatherisation at 6 month follow-up

  13. Currently participating in another trial and not yet at its primary endpoint.

    Angiographic exclusion criteria:

  14. The patient has a planned intervention in three separate major epicardial territories (3 vessel disease)
  15. The patient has a planned intervention in the left-main plus two separate major epicardial territories (left-main plus 2 vessel disease)
  16. Target vessel size >2.50 mm
  17. Target lesion has a total occlusion or TIMI flow <2
  18. Target lesion in left main stem
  19. The target vessel contains visible thrombus
  20. Target Restenotic lesion
  21. Aorto-ostial target lesion (within 3 mm of the aorta junction)
  22. 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
  23. Lesion is located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913832


Contacts
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Contact: Dario Gattuso +39 329 246 7132 dario@conceptmedicals.com

Locations
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Italy
Maria Cecilia Hospital spa Recruiting
Cotignola, Emilia-Romagna, Italy, 48033
Contact: Antonio Colombo, Dr.    39 0545 217111    ac84344@gmail.com   
Contact: Letizia Lunetto       llunetto@gvmnet.it   
Principal Investigator: Antonio Colombo, Dr         
Sub-Investigator: Francesco Giannini, Dr         
Sub-Investigator: Antonio Mangieri, Dr         
I.R.C.C.S. Policlinico San Donato Recruiting
San Donato Milanese, Lombardy, Italy, 20097
Contact: Luca Testa, Dr.    39 02 527741    luctes@gmail.com   
Principal Investigator: Luca Testa, Dr.         
AOUC Azienda Ospedaliero-Universitaria Careggi Recruiting
Firenze, Tuscany, Italy, 50134
Contact: Carlo di Mario, Dr    (+ 39) 055 794 111    carlo.dimario@unifi.it   
Principal Investigator: Carlo di Mario, Dr         
Sub-Investigator: Pierluigi Demola, Dr         
Sub-Investigator: Alessio Mattesini, Dr         
United Kingdom
Heart of England NHS Trust, Heartlands Hospital Not yet recruiting
Birmingham, United Kingdom
Contact: Sandeep Basavarajaiah, Dr    44 121 424 2000    sandeep270478@gmail.com   
Principal Investigator: Sandeep Basavarajaiah, Dr         
Worcestershire Royal Hospital Not yet recruiting
Worcester, United Kingdom
Contact: Helen Routledge, Dr    44 1905 763333    h.routledge@nhs.net   
Principal Investigator: Helen Routledge, Dr         
Sponsors and Collaborators
Concept Medicals BV
Investigators
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Study Chair: Patrick Serruys, Dr NUIG Imaging CoreLab
Principal Investigator: Bernardo Cortese, Dr Clinica San Carlo - Paderno Dugnano
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Concept Medicals BV
ClinicalTrials.gov Identifier: NCT03913832    
Other Study ID Numbers: 180013
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: March 9, 2022
Last Verified: March 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Concept Medicals BV:
small vessel
sirolimus
drug coating balloon
Additional relevant MeSH terms:
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Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Sirolimus
Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
 Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs