The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)

The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery) - The post market surveillance of Lutonix Drug Coated Balloon Catheter (femoropopliteal artery)

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000033747

Enrollment

370

Registered

2018-08-14

Start date

2017-11-17

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

Femoropopliteal artery disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients within the scope indicated for the device, and presenting with de novo lesion(s) or restenotic lesion(s) (excluding in-stent stenosis) in the superficial femoral or popliteal artery with the reference vessel diameter of >=4 mm and <= 6 mm and length of <=15 cm who are treated in the sites contracted for the surveillance.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Primary patency at 6 and 12 months post procedure	—

Secondary

Measure	Time frame
- Target Limb Reintervention, unscheduled target limb amputation and target limb related death during the follow-up period - SAE during the follow-up period, which the relation to device or procedure cannot be denied - Device malfunction and adverse event during the follow-up period which the relation to device or procedure cannot be denied - Freedom from clinically-driven (including ABI, Rutherford Classification) TLR at 1 month, 6 months and 12 months post procedure - Duration of Lutonix DCB related DAPT at pre-procedure and during follow-up period	—

Measure

Time frame

- Target Limb Reintervention, unscheduled target limb amputation and target limb related death during the follow-up period - SAE during the follow-up period, which the relation to device or procedure cannot be denied - Device malfunction and adverse event during the follow-up period which the relation to device or procedure cannot be denied - Freedom from clinically-driven (including ABI, Rutherford Classification) TLR at 1 month, 6 months and 12 months post procedure - Duration of Lutonix DCB related DAPT at pre-procedure and during follow-up period

—

Countries

Japan

Contacts

Public ContactSoji Iida

Medicon Inc. Clinical Development

Soji.Iida@bd.com06-6203-6567

Outcome results