The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter

The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter - The post market surveillance of IN.PACT Admiral Drug-Coated Balloon Catheter

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000030540

Enrollment

300

Registered

2017-12-24

Start date

2018-01-26

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: This product is indicated for percutaneous transluminal angioplastyof de novo and non-stented restenotic lesions with length less than 200 mm in superficial femoral and popliteal arteries with reference vessel diameters of more than 4 mm and less than 7 mm.

Exclusion criteria

Exclusion criteria: NA

Design outcomes

Primary

Measure	Time frame
Primary patency at 6 month post index procedure	—

Secondary

Measure	Time frame
1)Freedom from rate of clinical driven target lesions revascularization (CD-TLR) at 30 days, 6 months and 12 months post index procedure 2)Procedure rate of all target lesions revascularization (TLR) at 30 days, 6 months and 12 months post index procedure 3)Major adverse event (MAE) composite and its individual components (all-cause mortality, clinical driven target vessel revascularization (CD-TVR), major target limb amputation, and thrombosis at the target lesion site ) at each of the follow-up points including within 30 days, 6 months and 12 months. 4)Primary patency at 12 months post index procedure 5)Device Success defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst below the rated burst pressure (RBP) 6)Procedural Success defined as residual stenosis of less than 50% (non-stented subjects) or less than 30% (stented subjects) by physician visual assessment 7)Clinical success defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge 8)Adverse Events through discharge 9)Physician evaluation of successful on-label procedure	—

Measure

Time frame

1)Freedom from rate of clinical driven target lesions revascularization (CD-TLR) at 30 days, 6 months and 12 months post index procedure 2)Procedure rate of all target lesions revascularization (TLR) at 30 days, 6 months and 12 months post index procedure 3)Major adverse event (MAE) composite and its individual components (all-cause mortality, clinical driven target vessel revascularization (CD-TVR), major target limb amputation, and thrombosis at the target lesion site ) at each of the follow-up points including within 30 days, 6 months and 12 months. 4)Primary patency at 12 months post index procedure 5)Device Success defined as successful delivery, inflation, deflation and retrieval of the intact study balloon device without burst below the rated burst pressure (RBP) 6)Procedural Success defined as residual stenosis of less than 50% (non-stented subjects) or less than 30% (stented subjects) by physician visual assessment 7)Clinical success defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge 8)Adverse Events through discharge 9)Physician evaluation of successful on-label procedure

—

Countries

Japan

Contacts

Public ContactKei Harada

Medtronic Japan Co.,Ltd. Post Market Surveillance, Japan Clinical and Medical Affairs

kei.harada@medtronic.com03-6776-0007

Outcome results