NCT03206762

JET-RANGER Trial - JETStream Atherectomy With Adjunctive Paclitaxel-Coated Balloon Angioplasty vs Plain Old Balloon Angioplasty Followed by Paclitaxel-Coated Balloon

JETStream AtheRectomy With Adjunctive Paclitaxel-Coated BallooN Angioplasty vs Balloon AnGioplasty Followed by Paclitaxel-Coated Balloon in Treating ComplEx Denovo FemoRopopliteal Arterial Disease (JET-RANGER)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 47 (actual)
• Sponsor: Midwest Cardiovascular Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

A prospective, multicenter, randomized study evaluating the use of Jetstream Atherectomy (JS) followed by DCB in comparison to the use of plain old balloon angioplasty (POBA) followed by DCB alone in the treatment of complex lesions in femoropopliteal arteries in subjects with claudication (Rutherford Clinical Category (RCC) of 2-4) (complex lesions are defined as long (≥ 10 cm) lesions, or moderately or highly calcified lesions, or chronic total occlusions irrespective of length).

Conditions

• Peripheral Vascular Disease

Interventions

Type	Name	Description
DEVICE	Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm	Jetstream Atherectomy with randomization to the Ranger or IN.PACT DCB Arm or the POBA+DCB (Ranger or IN.PACT) Arm

Timeline

• Start date: 2018-03-28
• Primary completion: 2023-05-16
• Completion: 2023-05-16
• First posted: 2017-07-02
• Last updated: 2023-10-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study