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Antineoplastic Agent

Paclitaxel 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

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1, 6, 12, 24, 36, 48 and 60 months (rct and pk substudy); 1, 6 and 12 months (lb substudy)

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing a special balloon coated with a drug to treat blocked arteries in the leg. It targets patients with specific artery blockages that are hard to treat with usual methods. The balloon opens the artery, and the drug helps keep it open by stopping scar tissue from forming. These drug-coated balloons have been shown to be effective in keeping arteries open.

Eligible Conditions

Peripheral Arterial Disease
Atherosclerosis
Arterial Occlusive Disease
Plaque Morphology
Atherosclerotic Plaque

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1, 6, 12, 24, 36, 48 and 60 months (rct and pk substudy); 1, 6 and 12 months (lb substudy)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1, 6, 12, 24, 36, 48 and 60 months (rct and pk substudy); 1, 6 and 12 months (lb substudy)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1, 6, 12, 24, 36, 48 and 60 months (rct and pk substudy); 1, 6 and 12 months (lb substudy) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Major Adverse Events (MAEs) (Primary Safety Endpoint)

Number of Participants With Primary Lesion Patency

Secondary study objectives

Changes in Healthcare Utilization Over Time

Duplex-defined Binary Restenosis (PSVR > 2.4) of the Target Lesion

Number of Clinical Events Committee (CEC) Adjudicated Events

+14 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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

Paclitaxel

2011

Completed Phase 4

~5450

RANGER™ Paclitaxel Coated Balloon

2017

Completed Phase 3

~440