A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent

A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent - RELIABLE

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000009551

Enrollment

Registered

2012-12-15

Start date

2012-12-15

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

Symptomatic occlusive disease of the peripheral arteries

Interventions

STENT

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Rutherford Category 2-4 (mild intermittent claudication to ischemic pain at rest). 2. The target lesion(s) has evidence of narrowing or blockage and can be stented. 3. The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.

Exclusion criteria

Exclusion criteria: 1. The subject has concomitant renal failure with a creatinine of >2.5 mg/dl or having dialysis treatment. 2. Subject has a history of bypass surgery on the study vessel. 3. Subject has a history of MI or stroke within 6 months of study procedure.

Design outcomes

Primary

Measure	Time frame
The proportion of subjects who are free of target limb failure at 12-months post study procedure.	—

Secondary

Measure	Time frame
Primary patency, Secondary patency, Rutherford category assessment, ABI, Quality of life measurements, Major Adverse Events, all AEs and SAEs, TVR/TLR rates, and Freedom from Stent fracture rate	—

Countries

Japan

Contacts

Public ContactSoji Iida

Medicon Inc. Clinical Development

Soji.Iida@bd.com06-6203-6567

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026