NCT02013193

Comparison of the Ranger™ Paclitaxel-Coated PTA Balloon Catheter and Uncoated PTA Balloons in Femoropopliteal Arteries

Prospective, Randomized, Multicentre Clinical Study of the Hemoteq Ranger™ Paclitaxel-Coated PTA Balloon Catheter (Ranger DCB) in Comparison to Uncoated PTA Balloons in Femoropopliteal Lesions

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 105 (actual)
• Sponsor: Hemoteq AG · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of this study is to prove the superior performance of the Ranger™ paclitaxel-coated PTA balloon catheter for angioplasty for femoropopliteal artery lesions when compared to non-coated balloons at six months post-procedure when comparing Late Lumen Loss (LLL). Study statistical hypothesis: The %-mean loss of luminal diameter as assessed by angiography at six months follow-up after treatment of the femoropopliteal artery with Ranger DCB study devices is lower than the %-mean loss of luminal diameter after treatment with uncoated PTA balloon control devices.

Conditions

• Peripheral Artery Disease
• Claudication
• Atherosclerosis
• Arteriosclerosis

Interventions

Type	Name	Description
DEVICE	Ranger DCB	After successful pre-dilatation the index lesion is treated with one or two Ranger DCB devices that completely cover the lesion. If two devices are deployed, overlap shall be minimal.
DEVICE	uncoated PTA balloon	The index lesion is treated with one or more uncoated standard PTA balloons that completely cover the lesion.

Timeline

• Start date: 2014-01-07
• Primary completion: 2016-06-16
• Completion: 2019-03-15
• First posted: 2013-12-17
• Last updated: 2019-12-23

Locations

11 sites across 3 countries: Austria, France, Germany