NCT01270945

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
43

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Jun 2011

Typical duration for phase_2

Geographic Reach
1 country

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 4, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 5, 2011

Completed
6 months until next milestone

Study Start

First participant enrolled

June 30, 2011

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2013

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2014

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2.3 years

First QC Date

January 4, 2011

Last Update Submit

March 28, 2025

Conditions

Patients Undergoing Repeat Peripheral Artery Revascularization

Outcome Measures

Primary Outcomes (1)

  • Safety and tolerability of CV-18C3

    adverse events, vitals signs, physical examination results and clinical laboratory values

    1 year

Secondary Outcomes (1)

  • Time to restenosis and restenosis rates compared between CV-18C3 and controls

    1 year

Study Arms (2)

CV-18C3 and standard of care

EXPERIMENTAL

CV-18C3 and standard of care

Drug: CV-18C3Procedure: Standard of Care

standard of care

ACTIVE COMPARATOR

Percutaneous revascularization

Procedure: Standard of Care

Interventions

CV-18C3DRUG

3.75mg/kg given IV for a period of 6 weeks, followed by subcutaneous administration

CV-18C3 and standard of care
Standard of CarePROCEDURE
CV-18C3 and standard of carestandard of care

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Sutter Heart & Vascular Institute

Sacramento, California, 95819, United States

Location

JFK Medical Center

Atlantis, Florida, 33462, United States

Location

River City Clinical Research

Jacksonville, Florida, 32207, United States

Location

Jacksonville Center for Clinical Research

Jacksonville, Florida, 32216, United States

Location

Mediquest Research Group

Ocala, Florida, 34471, United States

Location

John D. Archbold Memorial Hospital

Thomasville, Georgia, 31799, United States

Location

Univeristy of Cincinnati University Hospital

Cincinnati, Ohio, 45267, United States

Location

Methodist Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • El Sayed H, Kerensky R, Stecher M, Mohanty P, Davies M. A randomized phase II study of Xilonix, a targeted therapy against interleukin 1alpha, for the prevention of superficial femoral artery restenosis after percutaneous revascularization. J Vasc Surg. 2016 Jan;63(1):133-41.e1. doi: 10.1016/j.jvs.2015.08.069. Epub 2015 Oct 1.

    PMID: 26433546DERIVED

MeSH Terms

Interventions

bermekimabStandard of Care

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Hosam El-Sayed, M.D., Ph.D.

    Methodist Cardiovascular Surgery Associates

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 4, 2011

First Posted

January 5, 2011

Study Start

June 30, 2011

Primary Completion

September 30, 2013

Study Completion

April 30, 2014

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations

US(8)