Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation

Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observation - SHIMEJI trial

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000018314

Enrollment

Registered

2015-08-01

Start date

2013-12-01

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

arteriosclerosis obliterans

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. The arteriosclerosis obliterans patient treated with Zilver PTX for superficial femoral artery 2.The patients whose drug-eluting stent is implanted in the site that can be observed by endoscopy

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating women 2. Warfarin user

Design outcomes

Primary

Measure	Time frame
Angioscopic findings 1. The presence of absence of thrombus attachment 2. Dominant of neointimal coverage grade	—

Secondary

Measure	Time frame
Angioscopid findings 1. The color of thrombus (categorized as red, white, and mixed thrombus) 2. Quantitative assessment of thrombus (0-10%, 10-50%, and >50%) 3. Neointima distribution 4. Color and character of vessel wall at stenting site 5. The presence or absence of yellow plaque and quantitative assessment of yellow plaque (0-10%, 10-50%, and >50%) 6. The presence or absence of erosion and dissection Cardiovascular events 1. Cardiac death 2. Cerebral infarction 3. Myocardial infarction 5. Stent thrombosis (Definit or probable based on ARC definition) 6. Revascularization (UTVR, TVT, TLR) Safety 1. Major bleeding (symptomatic intracranial hemorrhage and fatal bleeding) 2. Gastrointestinal and mucosal bleeding 3. Adverse event Pharmacodynamic assessment 1. The relationship between angioscopic findings and platelet aggregation assessed by Verify NOW. 2. The relationship between CYP2C19 polymorphism and drug efficacy	—

Measure

Time frame

Angioscopid findings 1. The color of thrombus (categorized as red, white, and mixed thrombus) 2. Quantitative assessment of thrombus (0-10%, 10-50%, and >50%) 3. Neointima distribution 4. Color and character of vessel wall at stenting site 5. The presence or absence of yellow plaque and quantitative assessment of yellow plaque (0-10%, 10-50%, and >50%) 6. The presence or absence of erosion and dissection Cardiovascular events 1. Cardiac death 2. Cerebral infarction 3. Myocardial infarction 5. Stent thrombosis (Definit or probable based on ARC definition) 6. Revascularization (UTVR, TVT, TLR) Safety 1. Major bleeding (symptomatic intracranial hemorrhage and fatal bleeding) 2. Gastrointestinal and mucosal bleeding 3. Adverse event Pharmacodynamic assessment 1. The relationship between angioscopic findings and platelet aggregation assessed by Verify NOW. 2. The relationship between CYP2C19 polymorphism and drug efficacy

—

Countries

Japan

Contacts

Public ContactShinke Toshiro

Kobe University Graduate School of Medicine. Division of Cardiovascular Medicine

sinke@med.kobe-u.ac.jp078-382-5846

Outcome results