Ranger drug-coated balloon catheters post market surveillance

Ranger drug-coated balloon catheters post market surveillance - Ranger drug-coated balloon catheters post market surveillance

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000043774

Enrollment

200

Registered

2021-06-01

Start date

2021-08-13

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 Ranger DCB catheter

Exclusion criteria

Exclusion criteria: Not applicable

Design outcomes

Primary

Measure	Time frame
- Implementation rate of target lesion revascularization (TLR) - Occurrence rate of AE and device malfunction - Mortality rate	—

Secondary

Measure	Time frame
- Death of any cause and target limb amputation during the follow-up (procedure, pre-discharge, 1, 6, 12 and 24 months) period - SAE for which relation to the Ranger DCB or procedures cannot be denied during the follow-up period - Device malfunction and adverse event for which the relation to Ranger DCB or procedures cannot be denied during the follow-up period - Duration of Ranger DCB related DAPT at pre-procedure and during the follow-up period	—

Measure

Time frame

- Death of any cause and target limb amputation during the follow-up (procedure, pre-discharge, 1, 6, 12 and 24 months) period - SAE for which relation to the Ranger DCB or procedures cannot be denied during the follow-up period - Device malfunction and adverse event for which the relation to Ranger DCB or procedures cannot be denied during the follow-up period - Duration of Ranger DCB related DAPT at pre-procedure and during the follow-up period

—

Countries

Japan

Contacts

Public ContactYuji Kato

Boston Scientific Japan K.K. Clinical Affairs

JapanClinicalTrials@bsci.com03-6853-7500

Outcome results