NCT01783600

NanoCross BTK, a Prospective, Non-randomized, Multicenter, Controlled Trial Evaluating the Performance of the NanoCrossTM .014 Balloon Catheter in Infrapopliteal Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (actual)
• Sponsor: Flanders Medical Research Program · Network
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

The objective of this clinical evaluation is to evaluate the immediate and long-term (up to 12 months) outcome of NanoCrossTM balloon catheter (Covidien) in a prospective, non-randomised, controlled investigation for the treatment of patients with critical limb ischemia (Rutherford 4-5) due to the presence of lesions of minimally 10cm in length at the level of the below-the-knee arteries.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	NanoCross .014 balloon catheter

Timeline

• Start date: 2013-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2013-02-05
• Last updated: 2016-08-11

Locations

4 sites across 1 country: Belgium