18 and older, any sex, with Atherosclerosis. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
The Primary Effectiveness Endpoint-Acute Reduction of Percent Diameter StenosisPrimary· Index Procedure (Core-lab will analysis the procedural angiograms to assess the acute reduction of percent diameter stenosis (%DS))
Acute reduction of percent diameter stenosis (%DS) post atherectomy but prior to any adjunctive therapy, when compared to its baseline diameter stenosis (absolute mean percentage).
Group
Value
95% CI
Primary Cohort
39.3
± 16.1
Roll in Cohort
42.8
± 11.1
Overall Cohort
39.9
± 15.4
The Primary Safety Endpoint-The Rate of Major Adverse Event (MAE) at 30 Days Follow upPrimary· 30days
defined as all-cause death, target limb unplanned major amputation and/or target lesion revascularization (TLR), within 30 days post index procedure.
Group
Value
95% CI
Primary Cohort
60
Roll in Cohort
11
Overall Cohort
71
Adverse events — posted to ClinicalTrials.gov
Time frame: 1 year.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This clinical study is a prospective, non-randomized, multicenter, single-arm study to demonstrate the acceptable safety and performance of the JETSTREAM™ Atherectomy System (Jetstream) used during percutaneous peripheral vascular intervention in patients with occlusive atherosclerotic lesions in the native SFA and/or PPA. It is intended that all patients with qualifying lesions would be considered for enrollment and treated with the Jetstream System.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Boston Scientific Corporation
Last refreshed: 29 October 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03455855.