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NCT03064126 · ClinicalTrials.gov registry record · Phase 3
RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty
A Phase 3 study of Atherosclerosis and Peripheral Artery Disease, sponsored by Boston Scientific Corporation.
- Completed
- Registry status
- Phase 3
- Development phase
- 440
- Enrollment target
- 20
- Study locations
NCT03064126: Completed Phase 3 study of Atherosclerosis and Peripheral Artery Disease, sponsored by Boston Scientific Corporation.
NCT03064126 is a Phase 3 study of Atherosclerosis and Peripheral Artery Disease that has completed, run by Boston Scientific Corporation. The registered enrollment target is 440 participants, below the 1,059-participant average among 69 other Atherosclerosis trials with a reported enrollment target (58% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03064126, a Phase 3 study of Atherosclerosis and Peripheral Artery Disease, has completed, sponsored by Boston Scientific Corporation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 440 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
RCT outcome measure: Primary patency of the target lesion is determined by Peak Systolic Velocity Ratio (PSVR) ≤ 2.4 (by duplex ultrasound (DUS)) and freedom from clinically-driven Target Lesion Revascularization (TLR) within 12 months from procedure. Lesion patency is defined as freedom from more than 50% stenosis based on DUS PSVR comparing data within the treated segment to the proximal normal arterial segment. PSVR \>2.4 suggests \>50% stenosis. LB Substudy outcome measure: Primary patency
Conditions Studied
Interventions
- DRUG Paclitaxel
- DEVICE RANGER™ Paclitaxel Coated Balloon
- PROCEDURE Standard Balloon Angioplasty
Study Locations (20)
Florida
- South Florida Vascular Associates - Coconut Creek
- North Florida Regional Medical Center - Gainesville
- Mount Sinai Medical Center - Miami Beach
- AdventHealth Orlando - Orlando
- AdventHealth Sebring - Sebring
Indiana
- St. Joseph Hospital - Fort Wayne
- Community Hospital - Munster
Minnesota
- Mercy Hospital - Coon Rapids
- United Heart and Vascular Clinic - Saint Paul
New Jersey
- Hackensack University Medical Center - Hackensack
- Jersey Shore University Medical Center - Neptune City
Alabama
- Thomas Hospital - Fairhope
Colorado
- Rocky Mountain Regional VA Medical Center - Aurora
Connecticut
- The Vascular Experts - Stratford
Delaware
- Christiana Hospital - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 440 participants |
| Start Date | 2017-03-02 |
| Est. Completion | 2023-10-25 |
| Phase | Phase 3 |
What the finished NCT03064126 record still lists
NCT03064126 is an interventional study that assigns participants to a tested intervention. The registered 440 participants enrollment target is mid-sized for trials with a published cap, below the 1,059-participant average among 69 other Atherosclerosis trials with a reported enrollment target (58% lower).
The record links to 5 conditions, with Atherosclerosis appearing as the primary indexed condition, and to 3 interventions - of which Paclitaxel is the first listed.
NCT03064126 names 20 study sites across 13 states, led by Florida, Indiana, Minnesota.
Frequently Asked Questions
What is clinical trial NCT03064126 about?
NCT03064126 is a clinical study titled "RANGER™ Paclitaxel Coated Balloon vs Standard Balloon Angioplasty". 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™ Pac...
What is the current status of trial NCT03064126?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 440 participants. The study started on 2017-03-02. Estimated completion is 2023-10-25.
What conditions does trial NCT03064126 study?
This clinical trial studies the following conditions: Atherosclerosis, Peripheral Artery Disease, Plaque, Atherosclerotic, Artery Diseases, Peripheral, Occlusive Arterial Disease.
What interventions are being tested in trial NCT03064126?
The interventions under investigation include: Paclitaxel (DRUG), RANGER™ Paclitaxel Coated Balloon (DEVICE), Standard Balloon Angioplasty (PROCEDURE).
Who is sponsoring clinical trial NCT03064126?
This trial is sponsored by Boston Scientific Corporation, which has 280 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03064126 being conducted?
This trial has 20 study locations across Alabama, Colorado, Connecticut, Delaware, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Atherosclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03064126's enrollment target sits among peer trials
440 21st of 69 higher than 49 of 69 other Atherosclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Atherosclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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