A Comparative Study of Thrombus Removal Treatments Using the Japanese National Clinical Database

A Retrospective Comparative Study of Surgical Thrombectomy and Mechanical Aspiration Thrombectomy Using the Japanese National Clinical Database (NCD) - NCD-Surgical vs Aspiration Thrombectomy Study in Japan

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000061455

Enrollment

3700

Registered

2026-05-06

Start date

2025-06-30

Completion date

Unknown

Last updated

2026-09-14

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

Conditions

Acute Limb Ischemia

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients registered in the Japanese National Clinical Database in 2024, regardless of age or sex, with acute arterial occlusion involving the infrarenal aorta or lower-extremity arteries, who underwent either (1) mechanical aspiration thrombectomy using the Indigo System as the primary index revascularization strategy or (2) open surgical thromboembolectomy as the primary index revascularization strategy.

Exclusion criteria

Exclusion criteria: Cases involving non-lower-extremity vessels; simultaneous bilateral procedures; intraoperative thrombolytic therapy; bypass surgery or other complex procedures; and simultaneous use of both the Indigo System and open surgical thromboembolectomy.

Design outcomes

Primary

Measure	Time frame
Composite of 30-day all-cause mortality or major lower-extremity amputation (at or above the ankle) after the index revascularization procedure.	—

Secondary

Measure	Time frame
Thirty-day all-cause mortality; 30-day major lower-extremity amputation; recanalization status at completion of the index procedure; target-vessel reocclusion; target-lesion revascularization; reoperation; procedural complications, including compartment syndrome and major adverse cardiovascular events; and 6-month overall survival and major lower-extremity amputation, assessed exploratorily among patients with available follow-up data.	—

Measure

Time frame

Thirty-day all-cause mortality; 30-day major lower-extremity amputation; recanalization status at completion of the index procedure; target-vessel reocclusion; target-lesion revascularization; reoperation; procedural complications, including compartment syndrome and major adverse cardiovascular events; and 6-month overall survival and major lower-extremity amputation, assessed exploratorily among patients with available follow-up data.

—

Countries

Japan

Contacts

Public ContactMomoka Shimada

General Incorporated Association National Clinical Database Secretariat

office@ncd-core.jp03-3233-7459

Outcome results