N/A
Completed N=300
Pivotal Trial of a Novel Paclitaxel-Coated Percutaneous Angioplasty Balloon
Source: ClinicalTrials.gov NCT01858428 ↗Enrolled (actual)
300
Serious AEs
61.0%
Results posted
Jan 2018
Primary outcomePrimary: Patency at 12 Month Post-procedure — 53; 135 Participants
Summary
This study is designed to evaluate the safety and efficacy of a Paclitaxel-coated percutaneous transluminal angioplasty (PTA) Catheter in the treatment of patients with peripheral arterial disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Patency at 12 Month Post-procedure |
53; 135 | — |
| PRIMARY Freedom From Device and Procedure-related Death and Target Limb Major Amputation and Clinically-driven Target Lesion Revascularization |
79; 174 | — |
| SECONDARY Major Adverse Event (MAE) Rate in the Hospital and at 1, 6, 12, 24, 36, 48 and 60 Months Post-procedure |
17; 18 | — |
| SECONDARY Rate of Vascular Access and Bleeding Complications |
3; 8 | — |
| SECONDARY Rate of Clinically-driven Target Lesion Revascularization |
15; 16 | — |
| SECONDARY Rate of Target Lesion Revascularization |
17; 18 | — |
| SECONDARY Rate of Target Limb Major Amputation |
0; 0 | — |
| SECONDARY Mortality Rate |
2; 5 | — |
| SECONDARY Rate of Occurrence of Arterial Thrombosis of the Treated Segment |
0; 2 | — |
| SECONDARY Patency Rate and Freedom From Clinically-driven TLR |
58; 133 | — |
| SECONDARY Lesion Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% |
98; 196 | — |
| SECONDARY Technical Success of Achieving a Final In-lesion Residual Diameter Stenosis of ≤50% |
98; 196 | — |
| SECONDARY Per Subject Clinical Success Achieving no Major Adverse Events During the Procedure |
98; 196 | — |
| SECONDARY Per Subject Procedural Success Achieving no Major Adverse Events During the Procedure |
98; 196 | — |
| SECONDARY Change in Ankle-brachial Index (ABI) From Pre-procedure |
69; 132 | — |
Eligibility Criteria
Inclusion Criteria
- Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.
Exclusion Criteria
- Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated
Data sourced from ClinicalTrials.gov (NCT01858428). 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.