CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 440 enrolled
Drug / intervention
Paclitaxel +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03064126
NCT03064126Phase 3Completed
CompareCT.gov

RANGER II SFA: A 3:1 Randomized Trial Comparing the Boston Scientific RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty for the Treatment of Superficial Femoral Arteries (SFA) and Proximal Popliteal Arteries (PPA)

Boston Scientific Corporation·interventional·Posted Feb 24, 2017·Updated Oct 29, 2024

In Brief

A Phase 3 clinical trial evaluating RANGER™ Paclitaxel Coated Balloon, Paclitaxel, and 1 other intervention for Peripheral Artery Disease and 4 related conditions. Completed, enrolled 440 participants across 67 sites in 6 countries.

Detailed Summary

To evaluate the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions located in the superficial femoral and proximal popliteal arteries (SFA/PPA). Long Balloon substudy: To evaluate the safety and effectiveness of the Boston Scientific Corporation (BSC) Ranger™ Paclitaxel Coated Balloon in the 120, 150 and 200 mm lengths for treating Superficial Femoral Artery (SFA) and/or Proximal Popliteal Artery (PPA) lesions.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral Artery Disease, Atherosclerosis, Artery Diseases, Peripheral, Plaque, Atherosclerotic, Occlusive Arterial Disease
CountriesAustria, Belgium, Canada, Japan, New Zealand, United States
Collaborators--

Timeline

Phase 3CompletedFinished
2017201820192020202120222023202420252026
First PostedFeb 24, 2017
Enrollment StartMar 2, 2017
Primary CompletionNov 18, 2019
Study CompletionOct 25, 2023
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 9.4 years ago

Interventions

RANGER™ Paclitaxel Coated Balloondevice

A procedure that utilizes a balloon coated with paclitaxel (drug) which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.

Paclitaxeldrug

The RANGER™ Balloon is coated with the drug Paclitaxel.

Standard Balloon Angioplastyprocedure

A procedure that utilizes an uncoated balloon which can open up a blocked blood vessel using a small, flexible plastic tube, or catheter, with a "balloon" at the end of it. When the tube is in place, it inflates to open the blood vessel, or artery, so that normal blood flow is restored. The tube is then removed. The blood vessels that will be treated in the RANGER II SFA study include the superficial femoral arteries and the proximal popliteal arteries.