Prevention of Restenosis Following Revascularization

NCT00518284 | Terminated Phase 2 Results

• 1 other identifier: CVR002
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 7

Brief Summary

The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)

Conditions

Vascular Disease, Peripheral

Keywords

Restenosis; Superficial Femoral Artery; Prevention of restenosis; Revascularization of the superficial Femoral Artery

Outcome Measures

Primary Outcomes (1)

• Target Vessel Revascularization at 9 Months

  Target vessel revascularization (TVR) was defined as percutaneous revascularization or bypass of the target lesion or any segment of the artery containing the target lesion. The percentage of participants requiring revascularization of the target vessel was determined by stenosis of \> 50% confirmed by angiography.

  9 months

Secondary Outcomes (11)

• Systolic Velocity Ratio (SVR) > 2.0

  9 months

• Change From Baseline in Walking Impairment Questionnaire (WIQ) Score

  Baseline and Month 9

• Decrease in Ankle Brachial Index (ABI) > 0.15

  Baseline and Month 9

• Target Lesion Revascularization (TLR) at 9 Months

  9 months

• Number of Deaths

  Up to 11 months

Study Arms (4)

No Drug Treatment Control

NO INTERVENTION

Following revascularization, participants did not receive any study drug treatment.

Proximal to Lesion + IV

EXPERIMENTAL

Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m\^2 at 7 days.

Drug: Nanoparticle Paclitaxel

During Flow Arrest

EXPERIMENTAL

Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.

Drug: Nanoparticle Paclitaxel

During Flow Arrest + IV

EXPERIMENTAL

Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m\^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m\^2 at 7 days.

Drug: Nanoparticle Paclitaxel

Interventions

Nanoparticle Paclitaxel DRUG

Nanoparticle albumin-bound paclitaxel, 45 mg/m\^2.

Also known as: ABI-007, Abraxane®, Coroxane™

During Flow Arrest; During Flow Arrest + IV; Proximal to Lesion + IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or non-pregnant and non-lactating female and greater than or equal to 18 years of age. All females if child bearing potential must have a negative serum pregnancy test
• Patient is determined to have peripheral artery disease (PAD) classified as Rutherford category 1-4 (grade I/II) - mild, moderate, or severe claudication or ischemic rest pain
• Patient has de novo lesion causing occlusion or an angiographic stenosis of at least 50% in the superficial femoral artery
• Patient has a single or multiple lesions located in the superficial femoral artery with a total length 5-15 cm.
• Normal vessel diameter of the SFA is 4-6 mm
• Patient must have a visibly patent (by angiography) popliteal artery below the target lesion
• No residual flow limiting dissection or residual stenosis greater 30% (visual estimate) after percutaneous balloon angioplasty (PTA) or provisional stenting. Treatment with provisional stenting will be allowed only for flow-limiting dissection, grade C/D or greater than 30 % residual stenosis angiographically after angioplasty alone.
• No target vessel thrombosis confirmed angiography post-PTA procedure
• No distal embolization within target limb
• Patient or his/her legally authorized representative or guardian has been informed about the nature of the study, and has agreed to participate in the study, and signed the Informed Consent Form prior to any premedication, prior to performance of revascularization procedures, and prior to participation in any study-related activities

You may not qualify if:

• Women of child bearing potential who do not use adequate contraception
• Patients who have experienced acute onset of claudication
• History of bleeding diathesis, coagulopathy, platelet disorder, or thrombocytopenia
• Patients with lesions requiring treatment with atherectomy or primary stenting
• Target lesion in which PTA failure would require treatment by provisional stenting with more than 2 stents
• Patient has a life expectancy of less than 36 months or there are factors making clinical follow up difficult (no fixed address, etc)
• Additional planned vascular procedure in treated extremity (note that concurrent endovascular treatment of iliac disease is allowable)
• Patient is immunosuppressed or is HIV positive
• Any individual who may refuse a blood transfusion
• Documented major gastrointestinal bleeding within 3 months
• Serum creatinine greater or equal to 2.5 mg/dl
• Platelet count less than 100,000 cells/mm\^3
• Uncorrectable coagulopathy with international normalized ratio (INR) greater than 2.0
• Absolute Neutrophil Count (ANC) less than 2000 cells mm\^3
• Hemoglobin (Hgb) less than 9 g/dl

Sponsors & Collaborators

• Celgene Corporation: lead

Study Sites (7)

UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400

Sacramento, California, 95817, United States

Location

Vascular & Interventional Physicians

Gainsville, Florida, 32605, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Michigan Vascular Research Center

Flint, Michigan, 48507, United States

Location

Holy Name Hospital

Teaneck, New Jersey, 07666, United States

Location

Lindner Clinical Trials Center

Cincinnati, Ohio, 45219, United States

Location

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

Location

MeSH Terms

Conditions

Peripheral Vascular Diseases

Interventions

Taxes; Albumin-Bound Paclitaxel

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Economics; Health Care Economics and Organizations; Paclitaxel; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes; Albumins; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Associate Director, Clinical Trials Disclosure
• Organization: Celgene Corporation

clinicaltrialdisclosure@celgene.com

1-888-260-1599

Study Officials

• José Iglesias, MD

  Celgene Corporation

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 16, 2007
• First Posted: August 20, 2007
• Study Start: January 1, 2008
• Primary Completion: August 1, 2009
• Study Completion: September 1, 2009
• Last Updated: March 13, 2012
• Results First Posted: March 13, 2012

Record last verified: 2012-02

Locations

US (7)