N/A
Completed N=50
Effects of Paclitaxel on Intimal Hyperplasia
Source: ClinicalTrials.gov NCT01454778 ↗Enrolled (actual)
50
Serious AEs
4.0%
Results posted
May 2016
Primary outcomePrimary: Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months — 0.93 ratio
Summary
This is a single, one time, limited dose infusion of Paclitaxel, that will potentially prevent recurrent stenosis secondary to intimal hyperplasia when compared to the control group at 10 months.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Evidence of Stenosis Lower Extremity Post Revascularization Using Ankle-Brachial Index Measurement at 10 Months |
0.93 | — |
| PRIMARY Rutherford Classification of Peripheral Arterial Disease |
0.63 | — |
| SECONDARY Freedom From Amputation Event |
100 | — |
| SECONDARY Freedom From Target Vessel Revascularization Event |
86 | — |
| SECONDARY Freedom From Binary Restenosis |
80 | — |
| SECONDARY Number of Serious Adverse Events |
2 | — |
Eligibility Criteria
Inclusion Criteria
- ability to provide informed consent
- age 18-90 years old
- Rutherford 1-6
- occlusion or stenosis in the infrainguinal vessels
Exclusion Criteria
- inability to pass the guide wire across the lesion
- pregnant or lactating women
- specific limb has not been previously treated with endovascular intervention
Data sourced from ClinicalTrials.gov (NCT01454778). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.