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NCT01858428 · ClinicalTrials.gov registry record · NA
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
A NA study of Peripheral Arterial Disease, sponsored by Spectranetics Corporation.
- Completed
- Registry status
- NA
- Development phase
- 300
- Enrollment target
- 20
- Study locations
NCT01858428: Completed NA study of Peripheral Arterial Disease, sponsored by Spectranetics Corporation.
NCT01858428 is a NA study of Peripheral Arterial Disease that has completed, run by Spectranetics Corporation. The registered enrollment target is 300 participants, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01858428, a NA study of Peripheral Arterial Disease, has completed, sponsored by Spectranetics Corporation.
- COMPLETED
- Registry status
- NA
- Development phase
- 300 participants
- Enrollment target
- 20
- Study locations
Study Summary
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
Primary Outcome
Patency is defined as the absence of target lesion restenosis as determined by duplex ultrasound (Peak Systolic Velocity Ratio (PSVR) ≤ 2.5) and freedom from clinically-driven target lesion revascularization.
Conditions Studied
Interventions
- DEVICE Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter
- DEVICE EverCross Percutaneous Transluminal Balloon Catheter
Study Locations (20)
Florida
- Cardiovascular Research of North Florida - Gainesville
- Baptist Cardiac and Vascular Institute - Miami
- Coastal Vascular and Interventional - Pensacola
California
- Mission Cardiovascular Research Institute - Fremont
- Good Samaritan Hospital - Los Angeles - Los Angeles
Georgia
- Emory University Hospital - Atlanta
- Northside Hospital - Atlanta
Michigan
- Cardiac & Vascular Research Center of Northern Michigan - Petoskey
- Metro Health Hospital - Wyoming
North Carolina
- Mission Hospital - Asheville
- Rex Hospital - Raleigh
Arizona
- Yuma Regional Medical Center - Yuma
Colorado
- Medical Center of the Rockies - Loveland
Connecticut
- Yale University School of Medicine - New Haven
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 300 participants |
| Start Date | 2013-06-18 |
| Est. Completion | 2018-03-19 |
| Phase | NA |
What the finished NCT01858428 record still lists
NCT01858428 is an interventional study that assigns participants to a tested intervention. The registered 300 participants enrollment target is mid-sized for trials with a published cap, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower).
The record links to 1 condition, with Peripheral Arterial Disease appearing as the primary indexed condition, and to 2 interventions - of which Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter is the first listed.
NCT01858428 names 20 study sites across 14 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT01858428 about?
NCT01858428 is a clinical study titled "Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon". This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
What is the current status of trial NCT01858428?
This trial is currently completed. It is a NA study. The enrollment target is 300 participants. The study started on 2013-06-18. Estimated completion is 2018-03-19.
What conditions does trial NCT01858428 study?
This clinical trial studies the following conditions: Peripheral Arterial Disease.
What interventions are being tested in trial NCT01858428?
The interventions under investigation include: Cardiovascular Ingenuity (CVI) Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter (DEVICE), EverCross Percutaneous Transluminal Balloon Catheter (DEVICE).
Who is sponsoring clinical trial NCT01858428?
This trial is sponsored by Spectranetics Corporation, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01858428 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01858428's enrollment target sits among peer trials
300 14th of 79 higher than 64 of 79 other Peripheral Arterial Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Peripheral Arterial Disease 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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