Safety and Preliminary Efficacy Study of an Anti-inflammatory Therapeutic Antibody in Reducing Restenosis.

Completed · Phase 2

Conditions studied: Patients Undergoing Repeat Peripheral Artery Revascularization

In brief

The purpose of this study is to determine if CV-18C3 will reduce the rate of restenosis or the time to restenosis in patients undergoing repeat peripheral artery revascularization versus controls randomized to standard of care.

Key facts

Study ID

NCT01270945

Run by

Janssen Research & Development, LLC

People needed

43

Starts

2011-06-30

Expected to finish

2014-04-30

Last updated by the study team

2025-03-30

Who can join

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

You may qualify if…

• Have suspected superficial femoro-popliteal artery occlusion due to lower extremity pain with exercise or at rest and are undergoing a planned arteriogram.
• Subjects will be randomized after angiographic evidence of qualifying lesion

You may not qualify if…

• Acute critical limb ischemia
• History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
• Any surgical or medical condition, which in the opinion of the investigator, may place the patient at higher risk from his/her participation in the study, or is likely to prevent the patient from complying with the requirements of the study or completing the study.

Where it is running

• Sutter Heart & Vascular Institute — Sacramento, California, United States
• JFK Medical Center — Atlantis, Florida, United States
• River City Clinical Research — Jacksonville, Florida, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Mediquest Research Group — Ocala, Florida, United States
• John D. Archbold Memorial Hospital — Thomasville, Georgia, United States
• Univeristy of Cincinnati University Hospital — Cincinnati, Ohio, United States
• Methodist Hospital — Houston, Texas, United States

Full record on ClinicalTrials.gov

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