Trial Outcomes & Findings for Prevention of Restenosis Following Revascularization (NCT NCT00518284)

NCT ID: NCT00518284

Last Updated: 2012-03-13

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 6 participants
• Primary outcome timeframe: 9 months
• Results posted on: 2012-03-13

Participant Flow

Participant milestones

Measure	Control Following revascularization, participants did not receive any study drug treatment.	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.	During Flow Arrest Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	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.
Overall Study STARTED	0	3	1	2
Overall Study COMPLETED	0	0	0	0
Overall Study NOT COMPLETED	0	3	1	2

Reasons for withdrawal

Measure	Control Following revascularization, participants did not receive any study drug treatment.	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.	During Flow Arrest Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	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.
Overall Study Adverse Event	0	1	0	0
Overall Study Study Termination	0	2	1	2

Baseline Characteristics

Prevention of Restenosis Following Revascularization

Baseline characteristics by cohort

Measure	Control Following revascularization, participants did not receive any study drug treatment.	Proximal to Lesion + IV n=3 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.	During Flow Arrest n=1 Participants Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 Participants 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.	Total n=6 Participants Total of all reporting groups
Age Continuous	—	69.7 years STANDARD_DEVIATION 10.50 • n=7 Participants	84.0 years STANDARD_DEVIATION NA • n=5 Participants	69.0 years STANDARD_DEVIATION 12.73 • n=4 Participants	71.8 years STANDARD_DEVIATION 10.59 • n=21 Participants
Gender Female	—	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Gender Male	—	3 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants
Race/Ethnicity, Customized Asian	—	0 participants n=7 Participants	0 participants n=5 Participants	1 participants n=4 Participants	1 participants n=21 Participants
Race/Ethnicity, Customized White, Non-Hispanic and Non-Latino	—	3 participants n=7 Participants	1 participants n=5 Participants	1 participants n=4 Participants	5 participants n=21 Participants

PRIMARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

The percentage of participants with a systolic velocity ratio > 2.0 assessed using lower extremity arterial duplex ultrasound.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Month 9

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

The Walking Impairment Questionnaire (WIQ) is utilized to characterize a patient's walking ability. Scores range from 0 (no difficulty) to 100 (much difficulty).

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline and Month 9

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

The percentage of participants with a decrease in the Ankle Brachial Index (ABI) > 0.15.

Ankle Brachial Index = Systolic Ankle Pressure / Systolic Brachial Pressure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 11 months

Population: Treated population.

Number of patients who died due to any cause.

Outcome measures

Measure	Proximal to Lesion + IV n=3 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.	During Flow Arrest n=1 Participants Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 Participants 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.	Control Following revascularization, participants did not receive any study drug treatment.
Number of Deaths	1 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Up to 11 months

Population: Treated population.

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.

Outcome measures

Measure	Proximal to Lesion + IV n=3 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.	During Flow Arrest n=1 Participants Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 Participants 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.	Control Following revascularization, participants did not receive any study drug treatment.
Number of Participants With Myocardial Infarction (MI)	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: Up to 11 months

Population: Treated population.

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.

Outcome measures

Measure	Proximal to Lesion + IV n=3 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.	During Flow Arrest n=1 Participants Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 Participants 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.	Control Following revascularization, participants did not receive any study drug treatment.
Number of Participants With a Stroke	0 participants	0 participants	0 participants	—

SECONDARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Minimum lumen diameter (MLD) is defined as the smallest diameter in millimeters (mm) in the arterial segment of interest measured angiographically.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Day 1 (following revascularization) and 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Late loss is defined as minimum lumen diameter (MLD) immediately post-procedure minus MLD at the time of follow-up, in mm.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

Binary restenosis was defined by a >50% diameter stenosis at follow-up study, assessed by angiography.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 9 months

Population: Because the study was cancelled after only 6 patients were enrolled, this analysis was not performed.

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.

Outcome measures

Outcome data not reported

Adverse Events

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Proximal to Lesion + IV

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

During Flow Arrest

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

During Flow Arrest + IV

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Control Following revascularization, participants did not receive any study drug treatment.	Proximal to Lesion + IV n=3 participants at risk 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 n=1 participants at risk Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 participants at risk 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.
Cardiac disorders Cardiac arrest	— 0/0 • Up to 11 months	33.3% 1/3 • Up to 11 months	0.00% 0/1 • Up to 11 months	0.00% 0/2 • Up to 11 months

Other adverse events

Measure	Control Following revascularization, participants did not receive any study drug treatment.	Proximal to Lesion + IV n=3 participants at risk 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 n=1 participants at risk Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization.	During Flow Arrest + IV n=2 participants at risk 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.
Gastrointestinal disorders Diarrhoea	— 0/0 • Up to 11 months	33.3% 1/3 • Up to 11 months	0.00% 0/1 • Up to 11 months	0.00% 0/2 • Up to 11 months
Gastrointestinal disorders Pain in extremity	— 0/0 • Up to 11 months	33.3% 1/3 • Up to 11 months	0.00% 0/1 • Up to 11 months	0.00% 0/2 • Up to 11 months
Psychiatric disorders Disorientation	— 0/0 • Up to 11 months	33.3% 1/3 • Up to 11 months	0.00% 0/1 • Up to 11 months	0.00% 0/2 • Up to 11 months
Vascular disorders Haematoma	— 0/0 • Up to 11 months	33.3% 1/3 • Up to 11 months	0.00% 0/1 • Up to 11 months	0.00% 0/2 • Up to 11 months

Additional Information

Associate Director, Clinical Trials Disclosure

Celgene Corporation

Phone: 1-888-260-1599

Email: clinicaltrialdisclosure@celgene.com

Results disclosure agreements

• Principal investigator is a sponsor employee * Study data will not be published in part before complete multicenter data have been reported in full, unless more than 18 months have elapsed since completion of the Study. * Investigator/institution must supply copy of presentation or publication to Celgene 30 days of prior to submission for publication. Celgene may request in writing within that 30 days that Celgene Confidential Information be deleted or be granted a 60 day delay prior to publication for intellectual property filings.
• Publication restrictions are in place

Restriction type: OTHER