Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon

Completed · Not applicable

Conditions studied: Peripheral Arterial Disease

In brief

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.

Key facts

Study ID

NCT01858428

Run by

Spectranetics Corporation

People needed

300

Starts

2013-06-18

Expected to finish

2018-03-19

Last updated by the study team

2020-08-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

You may not qualify if…

• Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated

Where it is running

• Yuma Regional Medical Center — Yuma, Arizona, United States
• Mission Cardiovascular Research Institute — Fremont, California, United States
• Good Samaritan Hospital - Los Angeles — Los Angeles, California, United States
• Medical Center of the Rockies — Loveland, Colorado, United States
• Yale University School of Medicine — New Haven, Connecticut, United States
• Cardiovascular Research of North Florida — Gainesville, Florida, United States
• Baptist Cardiac and Vascular Institute — Miami, Florida, United States
• Coastal Vascular and Interventional — Pensacola, Florida, United States
• Emory University Hospital — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Advocate Health and Hospitals Corporation — Oakbrook Terrace, Illinois, United States
• St. Joseph Hospital — Fort Wayne, Indiana, United States
• Central Iowa Hospital Corporation — Des Moines, Iowa, United States
• Cardiac & Vascular Research Center of Northern Michigan — Petoskey, Michigan, United States
• Metro Health Hospital — Wyoming, Michigan, United States
• Jackson Heart Clinic — Jackson, Mississippi, United States
• Deborah Heart and Lung Center — Browns Mills, New Jersey, United States
• Mount Sinai Medical Center — New York, New York, United States
• Mission Hospital — Asheville, North Carolina, United States
• Rex Hospital — Raleigh, North Carolina, United States
• Wake Heart Research — Raleigh, North Carolina, United States
• Cleveland Clinic Foundation — Cleveland, Ohio, United States
• OhioHealth Research Institute — Columbus, Ohio, United States
• North Ohio Research LTD. — Elyria, Ohio, United States
• Jobst Vascular Institute — Toledo, Ohio, United States

Full record on ClinicalTrials.gov

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