- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00518284
Prevention of Restenosis Following Revascularization
21. februar 2012 oppdatert av: Celgene Corporation
A Phase II Trial of ABI-007 (Paclitaxel Albumin-bound Particles) for the Prevention of Restenosis Following Revascularization of the Superficial Femoral Artery (SFA)
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)
Studieoversikt
Status
Avsluttet
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
6
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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California
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Sacramento, California, Forente stater, 95817
- UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400
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Florida
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Gainsville, Florida, Forente stater, 32605
- Vascular & Interventional Physicians
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Iowa
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Davenport, Iowa, Forente stater, 52803
- Midwest Cardiovascular Research Foundation
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Michigan
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Flint, Michigan, Forente stater, 48507
- Michigan Vascular Research Center
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New Jersey
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Teaneck, New Jersey, Forente stater, 07666
- Holy Name Hospital
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Ohio
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Cincinnati, Ohio, Forente stater, 45219
- Lindner Clinical Trials Center
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Rhode Island
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Providence, Rhode Island, Forente stater, 02903
- Rhode Island Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- The following lab values at baseline are exclusionary:
- 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
- Total Bilirubin greater than 1.5 mg/dl
- Alanine transaminase (SGPT) greater than 2.5 x upper limit normal range (ULN)
- Aspartate transaminase (SGOT) greater than 2.5 x ULN
- Alkaline phosphatase greater than 2.5 x ULN
- Total cholesterol greater than 350 mg/dl or Low Density Lipoprotein greater than 200 mg/dl
- Known allergies/hypersensitivity/contraindication to the study drug, to taxanes, to any required study treatment:aspirin, heparin, clopidogrel bisulfate, stent materials, or to ticlopidine, or dipyridamole
- Patient treated with bivalirudin (Angiomax)
- Pre-existing sensory neuropathy of National Cancer Institute (NCI) Toxicity Grade >1
- Previous participation in another study with any investigational drug or device within the past 30 days or current enrollment in any other clinical protocol or investigational trial
- Renal failure requiring hemodialysis
- Lower extremity or pedal pulse
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Ingen inngripen: No Drug Treatment Control
Following revascularization, participants did not receive any study drug treatment.
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Eksperimentell: Proximal to Lesion + IV
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.
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Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Andre navn:
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Eksperimentell: During Flow Arrest
Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization.
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Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Andre navn:
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Eksperimentell: During Flow Arrest + IV
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.
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Nanoparticle albumin-bound paclitaxel, 45 mg/m^2.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Target Vessel Revascularization at 9 Months
Tidsramme: 9 months
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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.
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9 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
---|---|---|
Systolic Velocity Ratio (SVR) > 2.0
Tidsramme: 9 months
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The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.
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9 months
|
Change From Baseline in Walking Impairment Questionnaire (WIQ) Score
Tidsramme: Baseline and Month 9
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The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability.
Scores range from 0 (no difficulty) to 100 (much difficulty).
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Baseline and Month 9
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Decrease in Ankle Brachial Index (ABI) > 0.15
Tidsramme: Baseline and Month 9
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The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15. Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure. |
Baseline and Month 9
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Target Lesion Revascularization (TLR) at 9 Months
Tidsramme: 9 months
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Target lesion revascularization (TLR) was defined as repeat percutaneous intervention or bypass surgery of the previously treated target lesion (or blockage).
The percentage of participants requiring revascularization of the target lesion was determined by stenosis of > 50% confirmed by angiography.
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9 months
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Number of Deaths
Tidsramme: Up to 11 months
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Number of patients who died due to any cause.
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Up to 11 months
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Number of Participants With Myocardial Infarction (MI)
Tidsramme: Up to 11 months
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The number of patients experiencing Myocardial Infarction (MI) during the study.
Myocardial Infarction was defined as new pathologic Q waves of at least 0.04 seconds, or an increase in serum creatine kinase to more than twice the normal code together with a pathologic increase in myocardial isoenzymes.
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Up to 11 months
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Number of Participants With a Stroke
Tidsramme: Up to 11 months
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The number of patients experiencing a stroke during the study.
Stroke was defined as any sudden development of neurological deficits lasting more than 24 hours, and if a brain imaging study is performed it shows an infarction or hemorrhage.
A transient ischemic attack is a neurological deficit lasting less than 24 hours and, if an imaging study is performed, shows no evidence of infarction or hemorrhage.
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Up to 11 months
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Minimum Lumen Diameter
Tidsramme: 9 months
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Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.
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9 months
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Late Loss
Tidsramme: Day 1 (following revascularization) and 9 months
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Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.
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Day 1 (following revascularization) and 9 months
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Percentage of Participants With Binary Restenosis
Tidsramme: 9 months
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Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.
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9 months
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Diameter Stenosis
Tidsramme: 9 months
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Diameter stenosis is calculated as [1 - (minimum lumen diameter (MLD) / reference vessel diameter)] * 100, where the reference vessel diameter is the vessel diameter measured in a healthy segment of the target vessel proximal as close as possible to the lesion.
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9 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. januar 2008
Primær fullføring (Faktiske)
1. august 2009
Studiet fullført (Faktiske)
1. september 2009
Datoer for studieregistrering
Først innsendt
16. august 2007
Først innsendt som oppfylte QC-kriteriene
17. august 2007
Først lagt ut (Anslag)
20. august 2007
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
13. mars 2012
Siste oppdatering sendt inn som oppfylte QC-kriteriene
21. februar 2012
Sist bekreftet
1. februar 2012
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Kardiovaskulære sykdommer
- Arteriosklerose
- Arterielle okklusive sykdommer
- Aterosklerose
- Vaskulære sykdommer
- Perifer arteriell sykdom
- Perifere vaskulære sykdommer
- Molekylære mekanismer for farmakologisk virkning
- Antineoplastiske midler
- Tubulin modulatorer
- Antimitotiske midler
- Mitosemodulatorer
- Antineoplastiske midler, fytogene
- Paklitaksel
- Albuminbundet paklitaksel
Andre studie-ID-numre
- CVR002
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .
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