Suppression of vascular wall Healing after IMplantation of drug Eluting peripheral stent in Japanese patients with the Infra inguinal lesion: serial angioscopic observatio
Not Applicable
Recruiting
- Conditions
- arteriosclerosis obliterans
- Registration Number
- JPRN-UMIN000018314
- Lead Sponsor
- Kobe University Graduate School of Medicine. Division of Cardiovascular Medicine, Department of Internal Medicine.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 60
Inclusion Criteria
Not provided
Exclusion Criteria
1. Pregnant and lactating women 2. Warfarin user
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Angioscopic findings 1. The presence of absence of thrombus attachment 2. Dominant of neointimal coverage grade
- Secondary Outcome Measures
Name Time Method 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