Clinical trial NCT03913832: TReAtmeNt of Small Coronary Vessels: MagicTouch Sirolimus Coated Balloon
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Coronary Artery Disease
DCB
Keywords: small vessel
sirolimus
drug coating balloon
Lead sponsor: Concept Medicals BV
Sponsor class: INDUSTRY
First posted: 2019-04-12
Enrollment: 121
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility 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 (≤2.75mm 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.

Primary outcomes:
measure: Net Gain (mm) In-segment
timeFrame: 6 Months
Secondary outcomes:
measure: Device success
timeFrame: Post procedure (Right after the treatment with drug coated balloon)
measure: Procedure Success
timeFrame: Post procedure (Right after the treatment with drug coated balloon)
measure: Acute/subacute/early/late vessel closure/thrombosis
timeFrame: 1, 6 months and 12 Months
measure: Angiographic outcomes: late lumen loss
timeFrame: 6 months
measure: Angiographic outcomes:Minimal lumen diameter
timeFrame: 6 months
measure: Angiographic outcomes: Percent diameter stenosis
timeFrame: 6 months
measure: Angiographic outcomes: Restenosis rate
timeFrame: 6 months
measure: Device oriented Composite Endpoint (DoCE / TLF): Cardiac death
timeFrame: 1, 6 months and 12 Months
measure: Device oriented Composite Endpoint (DoCE / TLF): Target vessel: myocardial infarction (TV-MI)
timeFrame: 1, 6 months and 12 Months
measure: Device oriented Composite Endpoint (DoCE / TLF): clinically indicated target lesion revascularization(TLR)
timeFrame: 1, 6 months and 12 Months
Other outcomes:
Locations:
city: Galway
country: Ireland
facility: Galway University Hospital
city: Cotignola
country: Italy
facility: Maria Cecilia Hospital spa
state: Emilia-Romagna
city: San Donato Milanese
country: Italy
facility: I.R.C.C.S. Policlinico San Donato
state: Lombardy
city: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi
state: Tuscany
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Birmingham
country: United Kingdom
facility: Heart of England NHS Trust, Heartlands Hospital
Study officials:
affiliation: NUIG Imaging CoreLab
name: Patrick Serruys, Dr
role: STUDY_CHAIR
affiliation: Fondazione RIC
name: Bernardo Cortese, Dr
role: STUDY_CHAIR
References:
citation: 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.