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Study was terminated due to changing sponsor priorities, and was not based on safety or outcomes data.
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The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| During Flow Arrest | Experimental | Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nanoparticle Paclitaxel | Drug | Nanoparticle albumin-bound paclitaxel, 45 mg/m^2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Velocity Ratio (SVR) > 2.0 | The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound. | 9 months |
| Change From Baseline in Walking Impairment Questionnaire (WIQ) Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| José Iglesias, MD | Celgene Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UC Davis Medical Center, Ellison Ambulatory Care Center Cardiology Suite 3400 | Sacramento | California | 95817 | United States | ||
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Following revascularization, participants did not receive any study drug treatment. |
| FG001 | 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. |
| FG002 | During Flow Arrest | Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization. |
| FG003 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Following revascularization, participants did not receive any study drug treatment. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Number | percentage of participants | 9 months |
|
Up to 11 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Following revascularization, participants did not receive any study drug treatment. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cardiac arrest | Cardiac disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Associate Director, Clinical Trials Disclosure | Celgene Corporation | 1-888-260-1599 | clinicaltrialdisclosure@celgene.com |
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| ID | Term |
|---|---|
| D016491 | Peripheral Vascular Diseases |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D013660 | Taxes |
| D000068196 | Albumin-Bound Paclitaxel |
| ID | Term |
|---|---|
| D004467 | Economics |
| D004472 | Health Care Economics and Organizations |
| D017239 | Paclitaxel |
| D043823 | Taxoids |
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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).
| Baseline and Month 9 |
| Decrease in Ankle Brachial Index (ABI) > 0.15 | 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 |
| Target Lesion Revascularization (TLR) at 9 Months | 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. | 9 months |
| Number of Deaths | Number of patients who died due to any cause. | Up to 11 months |
| Number of Participants With Myocardial Infarction (MI) | 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. | Up to 11 months |
| Number of Participants With a Stroke | 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. | Up to 11 months |
| Minimum Lumen Diameter | Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically. | 9 months |
| Late Loss | Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm. | Day 1 (following revascularization) and 9 months |
| Percentage of Participants With Binary Restenosis | Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography. | 9 months |
| Diameter Stenosis | 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. | 9 months |
| Vascular & Interventional Physicians |
| Gainsville |
| Florida |
| 32605 |
| United States |
| Midwest Cardiovascular Research Foundation | Davenport | Iowa | 52803 | United States |
| Michigan Vascular Research Center | Flint | Michigan | 48507 | United States |
| Holy Name Hospital | Teaneck | New Jersey | 07666 | United States |
| Lindner Clinical Trials Center | Cincinnati | Ohio | 45219 | United States |
| Rhode Island Hospital | Providence | Rhode Island | 02903 | United States |
| Study Termination |
|
| BG002 | During Flow Arrest | Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization. |
| BG003 | 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. |
| BG004 | Total | Total of all reporting groups |
| years |
|
| Gender | Number | participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
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.
| OG002 | During Flow Arrest | Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization. |
| OG003 | 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. |
|
| Secondary | Systolic Velocity Ratio (SVR) > 2.0 | The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Number | percentage of participants | 9 months |
|
|
| Secondary | Change From Baseline in Walking Impairment Questionnaire (WIQ) Score | The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty). | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Mean | Standard Deviation | scores on a scale | Baseline and Month 9 |
|
|
| Secondary | Decrease in Ankle Brachial Index (ABI) > 0.15 | The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15. Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Number | percentage of participants | Baseline and Month 9 |
|
|
| Secondary | Target Lesion Revascularization (TLR) at 9 Months | 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. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Number | percentage of participants | 9 months |
|
|
| Secondary | Number of Deaths | Number of patients who died due to any cause. | Treated population. | Posted | Number | participants | Up to 11 months |
|
|
|
| Secondary | Number of Participants With Myocardial Infarction (MI) | 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. | Treated population. | Posted | Number | participants | Up to 11 months |
|
|
|
| Secondary | Number of Participants With a Stroke | 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. | Treated population. | Posted | Number | participants | Up to 11 months |
|
|
|
| Secondary | Minimum Lumen Diameter | Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Mean | Standard Deviation | mm | 9 months |
|
|
| Secondary | Late Loss | Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Mean | Standard Deviation | mm | Day 1 (following revascularization) and 9 months |
|
|
| Secondary | Percentage of Participants With Binary Restenosis | Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Number | percentage of participants | 9 months |
|
|
| Secondary | Diameter Stenosis | 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. | Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed. | Posted | Mean | Standard Deviation | percent diameter stenosis | 9 months |
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 1 | 3 | 1 | 3 |
| EG002 | During Flow Arrest | Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m^2 nanoparticle paclitaxel immediately following revascularization. | 0 | 1 | 0 | 1 |
| EG003 | 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. | 0 | 2 | 0 | 2 |
| Pain in extremity | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Disorientation | Psychiatric disorders | MedDRA | Systematic Assessment |
|
| Haematoma | Vascular disorders | MedDRA | Systematic Assessment |
|
| D043822 |
| Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
| D000418 | Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |