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Antineoplastic Agent

RANGER™ Paclitaxel Coated Balloon for Peripheral Arterial Disease (RANGER II SFA Trial)

Phase 3
Waitlist Available
Led By Thomas Zeller, MD
Research Sponsored by Boston Scientific Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Chronic symptomatic lower limb ischemia defined as Rutherford classification 2, 3, or 4;
Target lesion is in the native SFA and/or PPA down to the P1 segment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 months (6 months for lb substudy)
Awards & highlights

RANGER II SFA Trial Summary

This trial is testing the safety and effectiveness of the Ranger™ Paclitaxel Coated Balloon for treating lesions in the superficial femoral and proximal popliteal arteries. The long balloon substudy is testing the safety and effectiveness of the 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.

Eligible Conditions
  • Peripheral Arterial Disease
  • Arterial Occlusive Disease
  • Atherosclerosis
  • Atherosclerotic Plaque

RANGER II SFA Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have a chronic condition in your legs that causes symptoms like pain or difficulty walking.
Select...
You have ongoing symptoms of poor blood flow in your lower limbs, which are classified based on how severe they are.
Select...
The area of interest is the main artery in your thigh (SFA) or pelvis (PPA) down to a specific section (P1 segment).

RANGER II SFA Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 months (6 months for lb substudy)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months (6 months for lb substudy) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Major Adverse Events (MAEs) (Primary Safety Endpoint)
Number of Participants With Primary Lesion Patency
Secondary outcome measures
Number of CEC Adjudicated Events Through 12 Months
Number of Major Adverse Event (MAE) Assessment
Number of Participants With Clinical Success Rate Assessment
+7 more

RANGER II SFA Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: RANGER™ Paclitaxel Coated BalloonExperimental Treatment2 Interventions
RANGER™ Paclitaxel Coated Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
Group II: Standard Balloon AngioplastyActive Control1 Intervention
Standard Balloon Catheter angioplasty in the SFA/PPA at the index procedure. Subjects will be randomized 3:1 to the drug coated or standard angioplasty balloon.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RANGER™ Paclitaxel Coated Balloon
2017
Completed Phase 3
~440
Paclitaxel
2011
Completed Phase 4
~5380

Find a Location

Who is running the clinical trial?

Boston Scientific CorporationLead Sponsor
715 Previous Clinical Trials
934,050 Total Patients Enrolled
15 Trials studying Peripheral Arterial Disease
273,559 Patients Enrolled for Peripheral Arterial Disease
Thomas Zeller, MDPrincipal InvestigatorUniversitaets-Herzzentrum
14 Previous Clinical Trials
1,950 Total Patients Enrolled
11 Trials studying Peripheral Arterial Disease
1,342 Patients Enrolled for Peripheral Arterial Disease
Ravish Sachar, MDPrincipal InvestigatorUniversity of North Carolina - Rex Hospital
2 Previous Clinical Trials
119 Total Patients Enrolled
1 Trials studying Peripheral Arterial Disease
13 Patients Enrolled for Peripheral Arterial Disease

Media Library

Paclitaxel (Antineoplastic Agent) Clinical Trial Eligibility Overview. Trial Name: NCT03064126 — Phase 3
Peripheral Arterial Disease Research Study Groups: Standard Balloon Angioplasty, RANGER™ Paclitaxel Coated Balloon
Peripheral Arterial Disease Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT03064126 — Phase 3
Paclitaxel (Antineoplastic Agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03064126 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are people with the condition being studied still able to enroll in the research project?

"According to the website, this trial is no longer active. The study was originally posted on March 2nd, 2017 and was most recently edited on October 27th, 2022. There are presently 1253 other trials that are accepting participants."

Answered by AI

Does the RANGER™ Paclitaxel Coated Balloon have a good track record?

"The RANGER™ Paclitaxel Coated Balloon was first used in 1997 in a study at City of Hope Comprehensive Cancer Center. So far, 1140 completed studies have used this balloon. 874 clinical trials are currently ongoing, with many of them based in McKinney, Utah."

Answered by AI

What objectives does this research hope to accomplish?

"This clinical trial's primary outcome, which will be measured over a 12-month period (6 months for the LB substudy), is the number of major adverse events (MAEs) (primary safety endpoint). Secondary outcomes include the number of participants with clinical success rate assessment (defined as clinical success defined as procedural success without procedural complications including death, major target limb amputation, thrombosis of the target lesion, or clinically-driven TLR prior to discharge), procedural success of angioplasty procedure (defined as procedural success defined as residual stenosis of less than or equal to 50% [non-st"

Answered by AI

To what maladies is the RANGER™ Paclitaxel Coated Balloon most often applied?

"The RANGER™ Paclitaxel Coated Balloon is a device that is most frequently used to treat neoplasm metastasis. It has also shown efficacy in the treatment of kaposi sarcoma, advance directives, and fallopian tubes cancer."

Answered by AI

Is this clinical trial conducted in many different city locations?

"The study is based out of North Dallas Research Associates, but has 47 other sites in states such as Utah, West virginia, and Ohio."

Answered by AI

Does the RANGER™ Paclitaxel Coated Balloon have FDA approval?

"There is already some evidence of efficacy for RANGER™ Paclitaxel Coated Balloon, so it received a score of 3."

Answered by AI
Recent research and studies
~55 spots leftby Mar 2025