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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 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.

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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.

Conditions Studied

Peripheral Arterial Disease

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

FieldValue
Enrollment Target 300 participants
Start Date 2013-06-18
Est. Completion 2018-03-19
Phase NA

Sponsor

Spectranetics Corporation

6 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01858428

The ClinicalTrials.gov registry entry for NCT01858428 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 300 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 4,202-participant average among 79 other Peripheral Arterial Disease trials with a reported enrollment target (93% lower). The listed sponsor is Spectranetics Corporation, which has 6 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 14 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.