Jetstream Atherectomy System post market surveillance

Jetstream Atherectomy System post market surveillance - Jetstream Atherectomy System post market surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000048673

Enrollment

150

Registered

2022-08-25

Start date

2022-09-15

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Superficial femoral and proximal popliteal artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients intended to be treated with Jetstream Atherectomy System

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
- Occurrence rate of periprocedural complications (Distal emboli, etc.) related to Jetstream Atherectomy System - Procedural success - Mortality rate	—

Secondary

Measure	Time frame
- All death, target limb amputation and target lesion revascularization (TLR) during the follow-up (procedure, pre-discharge, 6, 12, 24 months) period - SAE for which relation to the Jetstream Atherectomy System or procedures cannot be denied during the follow-up period - Device malfunction and adverse event for which the relation to Jetstream Atherectomy System or procedures cannot be denied during the follow-up period - Duration of Jetstream Atherectomy System related DAPT at pre-procedure and during the follow-up period	—

Measure

Time frame

- All death, target limb amputation and target lesion revascularization (TLR) during the follow-up (procedure, pre-discharge, 6, 12, 24 months) period - SAE for which relation to the Jetstream Atherectomy System or procedures cannot be denied during the follow-up period - Device malfunction and adverse event for which the relation to Jetstream Atherectomy System or procedures cannot be denied during the follow-up period - Duration of Jetstream Atherectomy System related DAPT at pre-procedure and during the follow-up period

—

Countries

Japan

Contacts

Public ContactHiroshi Sakamoto

Boston Scientific Japan K.K. Clinical Affairs

Hiroshi.Sakamoto@bsci.com03-6853-7500

Outcome results