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

Phase 2

Completed

Brief Summary: 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.

Detailed Description: Restenosis of peripheral artery lesions remains a challenging problem to overcome after percutaneous revascularization of atherosclerotic disease in the femoropopliteal arterial system. Rates of restenosis are as high as 60% after a year. Treatment options include medical therapy, angioplasty, arthrectomy and stent placement. The heterogeneity of disease between patients, variable length of target lesions and presence of unpredictable physical forces requires individualized treatment plans.

Vascular response to injury appears to play an important role in the development of restenosis. IL-1α is a potent inflammatory cytokine that plays a central role in vascular inflammation and vascular smooth muscle proliferation--both in acute and chronic injury. CV-18C3 antagonizes the biologic activity of IL-1α and is theorized to prevent the early IL-1α mediated inflammation that leads to vascular smooth muscle hypertrophy and restenosis, as well as the late IL-1α mediated atherosclerotic plaque formation.

Recruitment & Eligibility

Inclusion Criteria

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

Exclusion Criteria

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.

Arm && Interventions

Group	Intervention	Description
CV-18C3 and standard of care	CV-18C3	CV-18C3 and standard of care
CV-18C3 and standard of care	Standard of Care	CV-18C3 and standard of care
standard of care	Standard of Care	Percutaneous revascularization

Primary Outcome Measures

Name	Time	Method
Safety and tolerability of CV-18C3	1 year	adverse events, vitals signs, physical examination results and clinical laboratory values

Secondary Outcome Measures

Name	Time	Method
Time to restenosis and restenosis rates compared between CV-18C3 and controls	1 year	Efficacy determination will be derived from observed rates of target vessel occlusion, time to occlusion, incidence of target vessel revascularization procedures and incidence of major adverse cardiovascular events (MACE). ABI measurements and quality of life questionnaire scores will also be collected. Treated subjects will be compared to those randomized to no treatment.

Locations (8): Jacksonville Center for Clinical Research
🇺🇸
Jacksonville, Florida, United States
Sutter Heart & Vascular Institute
🇺🇸
Sacramento, California, United States
Mediquest Research Group
🇺🇸
Ocala, Florida, United States
Univeristy of Cincinnati University Hospital
🇺🇸
Cincinnati, Ohio, United States
JFK Medical Center
🇺🇸
Atlantis, Florida, United States
John D. Archbold Memorial Hospital
🇺🇸
Thomasville, Georgia, United States
River City Clinical Research
🇺🇸
Jacksonville, Florida, United States
Methodist Hospital
🇺🇸
Houston, Texas, United States