AnGiographic Performance With A Sirolimus-elutiNG Balloon in the TrEatment of De Novo CoronaRy Artery Disease

NCT05471245 | Completed DMC

• 1 other identifier: GINGER
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 7

Brief Summary

Evaluate angiographic performance in long lesions of Sirolimus Eluting Balloon Magic Touch by Concept Medical

Conditions

Coronary Restenosis

Keywords

QCA; late loss; sirolimus eluting balloon

Outcome Measures

Primary Outcomes (2)

• late lumen loss at 9 months measured by quantitative coronary angiography

  QCA by core lab

  18 months

• incidence of adverse clinical events

  myocardial infarction, death, need for revascularization

  18 months

Study Arms (1)

angiographic evaluation

EXPERIMENTAL

QCA at 9 months

Device: Magic Touch SCB by Concept Medical Inc.

Interventions

Magic Touch SCB by Concept Medical Inc. DEVICE

PCI with drug-coated balloon

angiographic evaluation

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \>18 years
• Patients presenting with stable or unstable coronary artery disease (CAD) eligible for percutaneous coronary intervention (PCI) with de novo CAD in one or two separates major epicardial territories and at least one lesion suitable for sirolimus coated balloon (SCB);
• Reference vessel diameter (RVD) at the SCB target site ≥2.0 mm and ≤4.0 mm (by visual estimation and/or quantitative coronary angiography);
• Lesion length at the SCB target site ≥25 mm;
• Successful lesion preparation (full and homogenous pre-dilatation balloon expansion without type C-F dissection and/or TIMI flow=3 at the SCB target site;
• SCB-target lesion located in the same or other vessels treated by drug-eluting stent (DES) implantation;
• Patient able to understand and provide informed consent and comply with all study procedures including 9 months angiographic follow-up.

You may not qualify if:

• Patients participating in another clinical evaluation;
• Age \<18 years;
• Cardiogenic shock;
• Pregnancy or breastfeeding women; pregnancy test, either urine or blood test must be performed within 7 days prior to the index procedure in woman of child-bearing potential, and must not commit to initiating a pregnancy for 12 weeks after implantation, using effective contraception;
• Thrombus containing lesion;
• Unprotected left main as a target lesion unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
• Comorbidities with life expectancy \<6 months;
• Aorto-ostial target lesion (within 3 mm of the aorta junction); unless this lesion is treated with a DES and SCB inflated distally or on a branch or on a different vessel;
• Target lesion located within an arterial or saphenous vein graft or distal to a diseased arterial or saphenous vein graft;
• Every known allergy, intolerance or hypersensitivity to any medication used during the procedure and to drugs recommended after the procedure (e.g. aspirin, clopidogrel, ticagrelor, prasugrel);
• Severe chronic kidney disease (glomerular filtration rate\<30 ml/min/1.73 m2);
• Platelet count \<50,000cells/mm;
• Stroke within the previous 6 months;
• RVD at the SCB target site \<2.0 mm or \>4.0 mm (by visual estimation and/or QCA); target lesion with RVD larger than 4 mm can be treated with a DES and SCB inflated in other segments of the same or other vessels.

Sponsors & Collaborators

• Fondazione Evidence per Attività e Ricerche Cardiovascolari ONLUS: lead

Study Sites (7)

IRCCS Ospedale San Raffaele

Milan, Italy/MI, 20132, Italy

Location

Centro Cardiologico Monzino

Milan, Italy/MI, 20138, Italy

Location

IRCCS Ospedale Galeazzi Sant'Ambrogio

Milan, Italy/MI, 20157, Italy

Location

Istituto Clinico Humanitas

Rozzano, Italy/MI, 20089, Italy

Location

Policlinico Universitario Campus Bio-Medico

Roma, Italy/RM, 00128, Italy

Location

Policlinico Tor Vergata

Rome, Italy/RM, 00133, Italy

Location

AULSS 2 Marca Trevigiana Ospedale di Conegliano

Conegliano, Italy/TV, 31015, Italy

Location

Related Publications (11)

• Latib A, Colombo A, Castriota F, Micari A, Cremonesi A, De Felice F, Marchese A, Tespili M, Presbitero P, Sgueglia GA, Buffoli F, Tamburino C, Varbella F, Menozzi A. A randomized multicenter study comparing a paclitaxel drug-eluting balloon with a paclitaxel-eluting stent in small coronary vessels: the BELLO (Balloon Elution and Late Loss Optimization) study. J Am Coll Cardiol. 2012 Dec 18;60(24):2473-80. doi: 10.1016/j.jacc.2012.09.020. Epub 2012 Nov 14.

  PMID: 23158530 BACKGROUND

• Tang Y, Qiao S, Su X, Chen Y, Jin Z, Chen H, Xu B, Kong X, Pang W, Liu Y, Yu Z, Li X, Li H, Zhao Y, Wang Y, Li W, Tian J, Guan C, Xu B, Gao R; RESTORE SVD China Investigators. Drug-Coated Balloon Versus Drug-Eluting Stent for Small-Vessel Disease: The RESTORE SVD China Randomized Trial. JACC Cardiovasc Interv. 2018 Dec 10;11(23):2381-2392. doi: 10.1016/j.jcin.2018.09.009.

  PMID: 30522667 BACKGROUND

• Jeger RV, Farah A, Ohlow MA, Mangner N, Mobius-Winkler S, Weilenmann D, Wohrle J, Stachel G, Markovic S, Leibundgut G, Rickenbacher P, Osswald S, Cattaneo M, Gilgen N, Kaiser C, Scheller B; BASKET-SMALL 2 Investigators. Long-term efficacy and safety of drug-coated balloons versus drug-eluting stents for small coronary artery disease (BASKET-SMALL 2): 3-year follow-up of a randomised, non-inferiority trial. Lancet. 2020 Nov 7;396(10261):1504-1510. doi: 10.1016/S0140-6736(20)32173-5. Epub 2020 Oct 19.

  PMID: 33091360 BACKGROUND

• 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 BACKGROUND

• Cortese B, Testa L, Di Palma G, Heang TM, Bossi I, Nuruddin AA, Ielasi A, Tespili M, Perez IS, Milazzo D, Benincasa S, Latib A, Cacucci M, Caiazzo G, Seresini G, Tomai F, Ocaranza R, Torres A, Perotto A, Bedogni F, Colombo A. Clinical performance of a novel sirolimus-coated balloon in coronary artery disease: EASTBOURNE registry. J Cardiovasc Med (Hagerstown). 2021 Feb 1;22(2):94-100. doi: 10.2459/JCM.0000000000001070.

  PMID: 32740442 BACKGROUND

• Cortese B, Di Palma G, Latini R. Magic Touch(R): preliminary clinical evidence with a novel sirolimus drug coated balloon. Minerva Cardioangiol. 2018 Aug;66(4):508-517. doi: 10.23736/S0026-4725.18.04641-8. Epub 2018 Feb 19.

  PMID: 29458247 BACKGROUND

• Stone GW, Sabik JF, Serruys PW, Simonton CA, Genereux P, Puskas J, Kandzari DE, Morice MC, Lembo N, Brown WM 3rd, Taggart DP, Banning A, Merkely B, Horkay F, Boonstra PW, van Boven AJ, Ungi I, Bogats G, Mansour S, Noiseux N, Sabate M, Pomar J, Hickey M, Gershlick A, Buszman P, Bochenek A, Schampaert E, Page P, Dressler O, Kosmidou I, Mehran R, Pocock SJ, Kappetein AP; EXCEL Trial Investigators. Everolimus-Eluting Stents or Bypass Surgery for Left Main Coronary Artery Disease. N Engl J Med. 2016 Dec 8;375(23):2223-2235. doi: 10.1056/NEJMoa1610227. Epub 2016 Oct 31.

  PMID: 27797291 BACKGROUND

• Moussa ID, Klein LW, Shah B, Mehran R, Mack MJ, Brilakis ES, Reilly JP, Zoghbi G, Holper E, Stone GW. Consideration of a new definition of clinically relevant myocardial infarction after coronary revascularization: an expert consensus document from the Society for Cardiovascular Angiography and Interventions (SCAI). J Am Coll Cardiol. 2013 Oct 22;62(17):1563-70. doi: 10.1016/j.jacc.2013.08.720.

  PMID: 24135581 BACKGROUND

• Garcia-Garcia HM, McFadden EP, Farb A, Mehran R, Stone GW, Spertus J, Onuma Y, Morel MA, van Es GA, Zuckerman B, Fearon WF, Taggart D, Kappetein AP, Krucoff MW, Vranckx P, Windecker S, Cutlip D, Serruys PW; Academic Research Consortium. Standardized End Point Definitions for Coronary Intervention Trials: The Academic Research Consortium-2 Consensus Document. Circulation. 2018 Jun 12;137(24):2635-2650. doi: 10.1161/CIRCULATIONAHA.117.029289.

  PMID: 29891620 BACKGROUND

• Jeger RV, Eccleshall S, Wan Ahmad WA, Ge J, Poerner TC, Shin ES, Alfonso F, Latib A, Ong PJ, Rissanen TT, Saucedo J, Scheller B, Kleber FX; International DCB Consensus Group. Drug-Coated Balloons for Coronary Artery Disease: Third Report of the International DCB Consensus Group. JACC Cardiovasc Interv. 2020 Jun 22;13(12):1391-1402. doi: 10.1016/j.jcin.2020.02.043. Epub 2020 May 27.

  PMID: 32473887 BACKGROUND

• Mehran R, Dangas G, Abizaid AS, Mintz GS, Lansky AJ, Satler LF, Pichard AD, Kent KM, Stone GW, Leon MB. Angiographic patterns of in-stent restenosis: classification and implications for long-term outcome. Circulation. 1999 Nov 2;100(18):1872-8. doi: 10.1161/01.cir.100.18.1872.

  PMID: 10545431 BACKGROUND

MeSH Terms

Conditions

Coronary Restenosis

Condition Hierarchy (Ancestors)

Coronary Stenosis; Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Study Officials

• Antonio Colombo, MD

  Humanitas Research Hospital IRCCS, Rozzano-Milan

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: prospective enrolment of long lesions

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: July 22, 2022
• Study Start: May 23, 2023
• Primary Completion: October 8, 2025
• Study Completion: October 8, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (7)