Drug Coated Balloon Clinical Studies

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De Novo Lesions

Randomized Clinical Trials
Year Name Primary Investigator Study Aim (Primary) Endpoint Patients Further
Information
2018 BASKET-SMALL 2 Jeger R SQP vs. DES
Vessel: RD ≤ 3 mm
MACE @ 12-month follow-up 758 Summary
Pubmed
2017 PEPCAD Japan SVD Funatsu A DCB vs. POBA
Vessel: RD ≤ 2.75 mm, ≥ 2 mm
TVF @ 6-month follow-up 135 Summary
Pubmed
2017 AMI Feasibility Study Gobić D DCB vs. DES
Patients: STEMI (< 12 h)
MACE, LLL @ 6-month follow-up 75 Summary
Pubmed
2016 Clinical Value "Stent-less" PCI Nishiyama N DCB vs. DES TLR @ 8-month follow-up 60 Summary
Pubmed
Not Randomized Clinical Trials & Registries
Year Name Primary Investigator Study Aim (Primary) Endpoint Patients Further
Information
2019 DCB-only All-Comers Registry Rosenberg M DCB – ISR & De Novo TLR @ 9-month follow-up 1,025 Summary
Pubmed
2016 FFR-Guided DCB-Angioplasty Shin E DCB – De Novo
Vessel: RD ≤ 3.5 mm, ≥ 2.5 mm
LLL, FFR @ 9-month follow-up
MI, TLR @ 12-month follow-up
67 Summary
Pubmed
2014 SVD Registry Zeymer U DCB – De Novo
Vessel: RD ≤ 2.75 mm, ≥ 2.0 mm
TLR @ 9-month follow-up 447 Summary
Pubmed
B. Braun Melsungen AG
Sieversufer 8
12359 Berlin
Germany