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ACTIVE Clinical Trial – 9-Month Follow Up

Overview

Trial designProspective, multicentre, non-randomised
Primary endpointMajor adverse events at 9 months
Secondary endpointsPrimary patency, Acute success, Clinical success, ABI, and Walking capacity at 9 months
Number of subjects123 subjects with symptomatic PAD


Baseline Characteristics

Lesions (Baseline)
RVD (mm)7.62±1.18
Mean lesion length (mm)29.43±14.66
% stenosis (most severe)68.74±14.22
MLD (mm)2.39±1.17
Lesions (Procedural)
Direct stenting46.8%
Post procedure diameter stenosis (%±SD)14.61±6.99
Post procedure MLD (mm±SD)6.58±1.16
 

Primary Endpoint Shows Low MAE Rates

primary


Secondary Endpoints Show 99.3% Primary Patency

secondary


ACTIVE Results Show Improved Clinical Status and Ankle-Brachial Index

Assurant Cobalt Fontaine Class

Assurant Cobalt ABI

Assurant Cobalt Active Data

All values are mean (n).
The walking impairment questionnaire (WIQ) scores range from 0% (unable to perform due to severe claudication) to 100% (no impairment).
*P value (baseline vs 9-m) < 0.001

UC201301532b EN