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Coronary Artery DiseaseTRANSFORM INCT03913832

TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon

A study testing sirolimus drug coated balloon (SCB) and paclitaxel releasing coronary balloon catheter in people with Coronary Artery Disease and DCB, run by Concept Medicals BV at 6 sites in 3 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Coronary Artery Disease, DCB
What is being tested?
sirolimus drug coated balloon (SCB) and paclitaxel releasing coronary balloon catheter
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
121 participants
Where
6 sitesin 3 countries
Study dates
28 Aug 2020to 10 Sep 2023
Phase
Interventional
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 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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

Who cannot join

  • 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)
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  • 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.

Trial locations and contacts

6 sites in 3 countries.

6 sites in 3 countries

Italy4 sites

  • Maria Cecilia Hospital spa

    Cotignola, Emilia-Romagna, 48033

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134

  • Istituto Clinico Humanitas

    Rozzano

  • I.R.C.C.S. Policlinico San Donato

    San Donato Milanese, Lombardy, 20097

Other trials in Italy

Ireland1 site

  • Galway University Hospital

    Galway

Other trials in Ireland

United Kingdom1 site

  • Heart of England NHS Trust, Heartlands Hospital

    Birmingham

Other trials in United Kingdom

About this study

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

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

Read the 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.

Being tested
sirolimus drug coated balloon (SCB), paclitaxel releasing coronary balloon catheter
Keywords
small vessel, sirolimus, drug coating balloon
Medical subject headings
Coronary Artery Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • sirolimus drug coated balloon (SCB)Device

    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.

  • paclitaxel releasing coronary balloon catheterDevice

    SeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter.

Study groups in NCT03913832
Study groupRoleWhat they receive
sirolimus drug coated balloon (SCB)ExperimentalMagic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)
Receives: Device: sirolimus drug coated balloon (SCB)
paclitaxel releasing coronary balloon catheter.Active comparatorSeQuent PleaseTM (B. Braun Melsungen AG, Vascular Systems,Berlin, Germany) is a paclitaxel releasing coronary balloon catheter
Receives: Device: paclitaxel releasing coronary balloon catheter

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Net Gain (mm) In-segment

    The primary endpoint is in-segment (balloon treated area) Net Gain (mm) at 6 months post-procedure.

    Measured: 6 Months

Secondary outcomes (10)

  1. Device success

    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).

    Measured: Post procedure (Right after the treatment with drug coated balloon)

  2. Procedure Success

    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).

    Measured: Post procedure (Right after the treatment with drug coated balloon)

  3. Acute/subacute/early/late vessel closure/thrombosis

    Closure by restenosis or thrombosis (diameter stenosis of 100% and/or TIMI grade 0).

    Measured: 1, 6 months and 12 Months

  4. Angiographic outcomes: late lumen loss

    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).

    Measured: 6 months

  5. Angiographic outcomes:Minimal lumen diameter

    The smallest lumen diameter in the segment of interest

    Measured: 6 months

  6. Angiographic outcomes: Percent diameter stenosis

    The percentage of luminal narrowing of vessel segment of interest

    Measured: 6 months

  7. Angiographic outcomes: Restenosis rate

    Restenosis is defined as ≥50% diameter stenosis at follow-up.

    Measured: 6 months

  8. Device oriented Composite Endpoint (DoCE / TLF): Cardiac death

    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.

    Measured: 1, 6 months and 12 Months

  9. Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI)

    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.

    Measured: 1, 6 months and 12 Months

  10. Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR)

    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.

    Measured: 1, 6 months and 12 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Apr 2019
  2. Study start28 Aug 2020
  3. Primary completion10 Mar 2023 (estimated)
  4. Study completion10 Sep 2023 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
121 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03913832
Sponsor's protocol ID
180013
Acronym
TRANSFORM I
Status last verified
Oct 2022
First submitted
25 Mar 2019
Last updated
5 Oct 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Ono M, Kawashima H, Hara H, Katagiri Y, Takahashi K, Kogame N, Wykrzykowska JJ, Piek JJ, Doshi M, Sharif F, Onuma Y, Colombo A, Serruys PW, Cortese B. A Prospective Multicenter Randomized Trial to Assess the Effectiveness of the MagicTouch Sirolimus-Coated Balloon in Small Vessels: Rationale and Design of the TRANSFORM I Trial. Cardiovasc Revasc Med. 2021 Apr;25:29-35. doi: 10.1016/j.carrev.2020.10.004. Epub 2020 Oct 17.

    PubMed 33109476

Questions about this trial

What is this clinical trial studying?

A study testing sirolimus drug coated balloon (SCB) and paclitaxel releasing coronary balloon catheter in people with Coronary Artery Disease and DCB, run by Concept Medicals BV at 6 sites in 3 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 9 inclusion and 24 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: status not confirmed, as of the sponsor's last update on 5 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in Italy, Ireland, United Kingdom. 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.

Are results available for this study?

Results are not available in the source record.

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?

Net Gain (mm) In-segment (time frame: 6 Months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03913832, which also lists 1 linked publication.

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 5 Oct 2022.

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