Ranger drug-coated balloon catheters post market surveillance
Not Applicable
Recruiting
- Conditions
- Superficial femoral and proximal popliteal artery disease
- Registration Number
- JPRN-UMIN000043774
- Lead Sponsor
- Boston Scientific Japan K.K.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
Not provided
Exclusion Criteria
Not applicable
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Implementation rate of target lesion revascularization (TLR) - Occurrence rate of AE and device malfunction - Mortality rate
- Secondary Outcome Measures
Name Time Method - Death of any cause and target limb amputation during the follow-up (procedure, pre-discharge, 1, 6, 12 and 24 months) period - SAE for which relation to the Ranger DCB or procedures cannot be denied during the follow-up period - Device malfunction and adverse event for which the relation to Ranger DCB or procedures cannot be denied during the follow-up period - Duration of Ranger DCB related DAPT at pre-procedure and during the follow-up period