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

October 3, 2022 updated by: Concept Medicals BV

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

The study is a prospective, multinational (Italy, Ireland 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 (≤2.75 mm) with respect to Net Gain (mm) at 6 months follow-up

Study Overview

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 (≤2.75mm). 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 ≤2.75mm 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 Type

Interventional

Enrollment (Actual)

121

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Galway, Ireland
        • Galway University Hospital
      • Rozzano, Italy
        • Istituto Clinico Humanitas
    • Emilia-Romagna
      • Cotignola, Emilia-Romagna, Italy, 48033
        • Maria Cecilia Hospital SPA
    • Lombardy
      • San Donato Milanese, Lombardy, Italy, 20097
        • I.R.C.C.S. Policlinico San Donato
    • Tuscany
      • Firenze, Tuscany, Italy, 50134
        • AOUC Azienda Ospedaliero-Universitaria Careggi
      • Birmingham, United Kingdom
        • Heart of England NHS Trust, Heartlands Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 (≤2.75mm by QCA prior to pre-dilatation)
  4. Target lesion length ≤30 mm
  5. Able to understand and provide informed consent and comply with all study procedures including 6 months angiographic follow-up
  6. 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 >2.75 mm (by QCA)
  17. Target vessel size <2.00 mm (by QCA)
  18. Target lesion has a total occlusion or TIMI flow <2
  19. Target lesion in left main stem
  20. The target vessel contains visible thrombus
  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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Experimental: sirolimus drug coated balloon (SCB)
Magic TouchTM (Concept Medical) is a 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
SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 Months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Post procedure (Right after the treatment with drug coated balloon)
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).
Post procedure (Right after the treatment with drug coated balloon)
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).
1, 6 months and 12 Months
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).
6 months
Angiographic outcomes:Minimal lumen diameter
Time Frame: 6 months
The smallest lumen diameter in the segment of interest
6 months
Angiographic outcomes: Percent diameter stenosis
Time Frame: 6 months
The percentage of luminal narrowing of vessel segment of interest
6 months
Angiographic outcomes: Restenosis rate
Time Frame: 6 months
Restenosis is defined as ≥50% diameter stenosis at follow-up.
6 months
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.
1, 6 months and 12 Months
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.
1, 6 months and 12 Months
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.
1, 6 months and 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Study Chair: Patrick Serruys, Dr, NUIG Imaging CoreLab
  • Study Chair: Bernardo Cortese, Dr, Fondazione RIC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 28, 2020

Primary Completion (Anticipated)

March 10, 2023

Study Completion (Anticipated)

September 10, 2023

Study Registration Dates

First Submitted

March 25, 2019

First Submitted That Met QC Criteria

April 11, 2019

First Posted (Actual)

April 12, 2019

Study Record Updates

Last Update Posted (Actual)

October 5, 2022

Last Update Submitted That Met QC Criteria

October 3, 2022

Last Verified

October 1, 2022

More Information

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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