N/A
N=123
The ACTIVE (Use of the Assurant® Cobalt Iliac Stent System in the Treatment of Iliac Vessel Disease) Study
Peripheral Vascular Disease
Bottom Line
View on ClinicalTrials.gov: NCT00753337 ↗Enrolled (actual)
123
Serious AEs
30.1%
Results posted
Dec 2013
Primary outcome: Primary: Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR). — 0.8 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Assurant® Cobalt Iliac Stent System (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Medtronic Endovascular
- Primary completion
- Feb 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Major Adverse Events (MAE), Measured as Device and/or Procedure Related Death, Target Limb Loss and/or Clinically Driven Target Lesion Revascularization (TLR) or Target Vessel Revascularization (TVR). |
0.8 | — |
| SECONDARY Primary Patency Rate at 9 Months |
100 | — |
| SECONDARY Device Success |
97.5 | — |
| SECONDARY Lesion Success |
97.5 | — |
| SECONDARY Procedure Success |
96.7 | — |
| SECONDARY Clinical Success |
90.4 | — |
| SECONDARY Clinical Success |
90.4 | — |
| SECONDARY Hemodynamic Success |
55.2 | — |
| SECONDARY Hemodynamic Success |
55.2 | — |
| SECONDARY All Cause Mortality |
0.0 | — |
| SECONDARY All Cause Mortality |
0.0 | — |
Summary
The objective of this study is to evaluate the safety and efficacy of the Assurant Cobalt Iliac Stent System in the treatment of de novo and restenotic lesions in iliac arteries of subjects with Peripheral Artery Disease (PAD).
Eligibility Criteria
Inclusion Criteria
- The lesion(s) is either de novo or restenotic in nature, located in the common iliac artery and/or the external iliac artery;
- The subject is symptomatic (Fontaine stage II or III) with a target lesion stenosis ≥ 50% .
- The target vessel(s) reference diameter is ≥ 6 mm and ≤ 10 mm by visual estimate;
- The lesion length is 2.5 mg/dl
- Platelet count 700, 000 cells/mm3, or a white blood cell (WBC) of <3,000 cells/mm3
- Participation in another investigational device or drug study and has not completed the primary endpoint(s) or that clinically interferes with the study endpoints;
- Previously enrolled in the Study.
Data sourced from ClinicalTrials.gov (NCT00753337). 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.