NCT01273623

The Jetstream G3™ Calcium Study

A Prospective, Single-Arm Study to Evaluate the Effects of the Jetstream G3 System on Calcified Peripheral Vascular Lesions

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 55 (actual)
• Sponsor: Boston Scientific Corporation · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

Summary

To investigate the treatment effects with the Jetstream G3 System in moderate to severely calcified peripheral artery disease in the common femoral, superficial femoral or popliteal arteries using intravascular ultrasound (IVUS).

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Jetstream Atherectomy System	to perform atherectomy on calcified lesions

Timeline

• Start date: 2011-01-01
• Primary completion: 2012-03-01
• Completion: 2012-03-01
• First posted: 2011-01-10
• Last updated: 2015-11-18
• Results posted: 2015-05-04

Locations

5 sites across 1 country: United States