Innovative endovascular treatment strategy by angiography, IVUS and pressure gradient guidance in SFA disease with a new nitinol stent system -A prospective multicenter study-

Innovative endovascular treatment strategy by angiography, IVUS and pressure gradient guidance in SFA disease with a new nitinol stent system -A prospective multicenter study- - IGNITE study

Status

Active, not recruiting

Phases

Phase 4

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000021844

Enrollment

300

Registered

2016-04-09

Start date

2016-04-09

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 peripheral artery disease: -Moderate or severe claudication (Rutherford category 2 or 3) -Critical limb ischemia (Rutherford category 4 or 5)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1) Age 20 years or older 2) Symptomatic peripheral artery disease: -Moderate or severe claudication (Rutherford category 2 or 3) -Critical limb ischemia (Rutherford category 4 or 5) 3) Patients with signed informed consent Anatomical criteria: 1) Target lesion length <150 mm by angiographic estimation (TASC II A and B lesion) 2) Significant Stenosis or occlusion of the superficial femoral artery 3) De novo lesion

Exclusion criteria

Exclusion criteria: 1) Acute critical limb ischemia 2) Severe critical limb ischemia (Rutherford category 6) 3) Known hypersensitivity or contraindication to any of the following medications: heparin, aspirin, clopidogrel 4) Age < 20 years 5) Life expectancy <2 year due to comorbidity 6) Severe dementia or bedridden case Angiographic criteria 1) Target lesion length > 150 mm by angiographic estimation (TASC II C and D lesion) 2) Previous bypass surgery or stenting of the superficial femoral artery 3) Diseased CFA or distal popliteal artery (P2 or P3 segment) with stenosis more than 50%)

Design outcomes

Primary

Measure	Time frame
Primary patency of optimal balloon and bail-out stent at 12months which was defined as freedom from restenosis by DUS at rest peak systolic velocity ratio (PSVR) less than 2.5 with no reintervention	—

Secondary

Measure	Time frame
1) Freedom from Clinically Driven Target lesion revascularization 2) All-cause mortality 3) Myocardial infarction 4) Brain infarction 5) Freedom from conversion to bypass surgery involving the target lesion 6) Amputation free rate 7) Improve of Rutherford category 8) Ankle-brachial index at 12months 9) Primary patency at 6 months 10) Technical successful rate 11) Complication free rate	—

Countries

Japan

Contacts

Public ContactMasahiko Fujihara

Kishiwada Tokushukai Hospital Cardiology

masahiko-fujihara@themis.ocn.ne.jp072(445)9915

Outcome results