Table 14.
Types of drug-coated balloons with their regulatory approval status and clinical trials. BMS: bare-metal stents and ISR: in-stent restenosis.
| Balloon | Application | Clinical trials | Groups | CE Approval |
FDA Approval |
|---|---|---|---|---|---|
| PACCOCATH® COTAVANCETM MEDRADIN, USA |
Infrainguinal and iliac arteries | ISR I | PACCOCATH® DEB versus uncoated DEB | Yes, 2011 | No |
| ISR II (12 months) | |||||
| FEMPAC | Uncoated balloon, DEB | ||||
| THUNDER | Plain balloon, DEB, a drug with contrast media | ||||
| DIOR®, Eurocor GmbH, Germany | Coronary arteries | DIOR Registry | DEB after BMS-ISR, DES-ISR | No | No |
| Small coronary arteries | DEBUIT | DEB after BMS, DEB | YES, 2007 for coating | ||
| PICCOLETO | DES (versus) DEB | ||||
| VALENTINES II | Lesions with DEB | ||||
| DEB-AMI | DEB+BMS, BMS, Taxus® DES | ||||
| IN.PACT™Admiral™, Medtronic, USA |
Peripheral artery diseases (upper leg) |
IN.PACT™ SFA I | DEB (versus) plain balloon | Yes, 2009 | PMA 2015 |
| SeQuent® Please, B. Braun Vascular Systems, Germany |
Coronary artery and small vessels | PEPCAD I | Sequent™Please (versus) Sequent™Please+BMS |
Yes, 2009 | No |
| PEPCAD II | Sequent™Please (versus) Taxus® | ||||
| PEPCAD III | Sequent™Please + Coroflex™ DEBlue (versus) Cypher® | ||||
| PEPCAD IV | Sequent™Please (versus) Coroflex™DEBlue and Taxus® |
||||
| PEPCAD V | Sequent™Please (versus) Coroflex™DEBlue and Taxus |
||||
| PEPCAD DES | Sequent™Please (versus) plain balloon |
||||
| PEPCADCTO | Sequent™Please+BMS (versus) Taxus® | ||||
| INDICOR | BMS after Sequent™Please (versus) Sequent™Please after BMS |
||||
| PERFECT | Sequent™Please + EPC stent (versus) EPC stent | ||||
| ISAR DESIRE | Sequent™Please, DES, uncoated balloon |