Late Vascular Response Following Endovascular Treatment with Drug-coating Balloon for Femoropopliteal Artery Lesions as Assessed by Intravascular Ultrasound

Late Vascular Response Following Endovascular Treatment with Drug-coating Balloon for Femoropopliteal Artery Lesions as Assessed by Intravascular Ultrasound - ENLARGE study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000046511

Enrollment

100

Registered

2022-01-01

Start date

2021-12-09

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

Peripheral Artery Disease

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients with symptomatic PAD undergoing EVT for superficial femoral artery or proximal popliteal artery with DCB. 2. Age 20 years or older.

Exclusion criteria

Exclusion criteria: 1. Restenosis lesion. 2. Lesion treated with any stents. 3. Critical limb ischemia. 4. Life expectancy less than 1 year. 5. Pregnant or breastfeeding.

Design outcomes

Primary

Measure	Time frame
change in IVUS-derived lumen volume index (1-year follow up - post EVT)	—

Secondary

Measure	Time frame
Change in vessel volume index (1-year follow-up - post-EVT) Change in plaque volume index (1-year follow-up - post-EVT) Change in mean lumen area (1-year follow-up - post-EVT) Change in mean vessel area (1-year follow-up - post-EVT) Change in mean plaque area (1-year follow-up - post-EVT) Change in lumen volume index (post-EVT - baseline) Change in vessel volume index (post-EVT - baseline) Change in plaque volume index (post-EVT - baseline) Change in mean lumen area (post-EVT - baseline) Change in vessel area (post-EVT - baseline) Change in mean plaque area (post-EVT - baseline) Mean dissection angle at post-EVT Maximum dissection angle at post-EVT Mean dissection angle at 1-year Maximum dissection angle at 1-year Incidence of late lumen enlargement Restenosis at 1 year as assessed by duplex ultrasound (PSVR: peak systolic velocity rate > 2.4m/s) Late lumen loss (MLD at follow-up - MLD at post-EVT) by QVA Acute gain (MLD at post-EVT - MLD at baseline) by QVA Predictors for LLE at 1 year Predictors for restenosis at 1 year All-cause death, cardiac death, myocardial infarction, stroke, revascularization, amputation Sub-group analysis: Lesion length>20mm Plaque burden>70% Calcification angle>180 TASC classification Hemodialysis Diabetes mellitus Sex Small vessel %diameter stenosis at post-DCB Plaque type (lipid vs. fibrous vs. calcification)	—

Measure

Time frame

Change in vessel volume index (1-year follow-up - post-EVT) Change in plaque volume index (1-year follow-up - post-EVT) Change in mean lumen area (1-year follow-up - post-EVT) Change in mean vessel area (1-year follow-up - post-EVT) Change in mean plaque area (1-year follow-up - post-EVT) Change in lumen volume index (post-EVT - baseline) Change in vessel volume index (post-EVT - baseline) Change in plaque volume index (post-EVT - baseline) Change in mean lumen area (post-EVT - baseline) Change in vessel area (post-EVT - baseline) Change in mean plaque area (post-EVT - baseline) Mean dissection angle at post-EVT Maximum dissection angle at post-EVT Mean dissection angle at 1-year Maximum dissection angle at 1-year Incidence of late lumen enlargement Restenosis at 1 year as assessed by duplex ultrasound (PSVR: peak systolic velocity rate > 2.4m/s) Late lumen loss (MLD at follow-up - MLD at post-EVT) by QVA Acute gain (MLD at post-EVT - MLD at baseline) by QVA Predictors for LLE at 1 year Predictors for restenosis at 1 year All-cause death, cardiac death, myocardial infarction, stroke, revascularization, amputation Sub-group analysis: Lesion length>20mm Plaque burden>70% Calcification angle>180 TASC classification Hemodialysis Diabetes mellitus Sex Small vessel %diameter stenosis at post-DCB Plaque type (lipid vs. fibrous vs. calcification)

—

Countries

Japan

Contacts

Public ContactKeisuke Machida

Shinshu University Hospital Department of Cardiovascular Medicine

matchy0925@icloud.com0263-37-3486

Outcome results