TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon

NCT03913832 | Unknown DMC

• 1 other identifier: 180013
• Study Type: interventional
• Target: 121
• Locations: 3 countries
• Sites: 6

Brief 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). 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

Conditions

Coronary Artery Disease; DCB

Keywords

small vessel; sirolimus; drug coating balloon

Outcome Measures

Primary Outcomes (1)

• Net Gain (mm) In-segment

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

  6 Months

Secondary Outcomes (10)

• Device success

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

• Procedure Success

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

• Acute/subacute/early/late vessel closure/thrombosis

  1, 6 months and 12 Months

• Angiographic outcomes: late lumen loss

  6 months

• Angiographic outcomes:Minimal lumen diameter

  6 months

Study Arms (2)

sirolimus drug coated balloon (SCB)

EXPERIMENTAL

Magic TouchTM (Concept Medical) is a sirolimus drug coated balloon (SCB)

Device: sirolimus drug coated balloon (SCB)

paclitaxel releasing coronary balloon catheter.

ACTIVE COMPARATOR

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

Device: paclitaxel releasing coronary balloon catheter

Interventions

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.

sirolimus drug coated balloon (SCB)

paclitaxel releasing coronary balloon catheter DEVICE

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

paclitaxel releasing coronary balloon catheter.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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)

Sponsors & Collaborators

• Concept Medicals BV: lead

Study Sites (6)

Galway University Hospital

Galway, Ireland

Location

Maria Cecilia Hospital spa

Cotignola, Emilia-Romagna, 48033, Italy

Location

I.R.C.C.S. Policlinico San Donato

San Donato Milanese, Lombardy, 20097, Italy

Location

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy

Location

Heart of England NHS Trust, Heartlands Hospital

Birmingham, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 33109476 DERIVED

Related Links

• Study website

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Patrick Serruys, Dr

  NUIG Imaging CoreLab

  STUDY CHAIR

• Bernardo Cortese, Dr

  Fondazione RIC

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 25, 2019
• First Posted: April 12, 2019
• Study Start: August 28, 2020
• Primary Completion: March 10, 2023
• Study Completion: September 10, 2023
• Last Updated: October 5, 2022

Record last verified: 2022-10

Locations

IE (1); GB (1); IT (4)