Trials / Unknown
UnknownNCT02701816
Korean Multicenter Registry of INNOVA Stent for Femoropopliteal Artery Disease: (K-INNOVA Registry)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 150 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 19 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
* Prospective, single-arm, multi-center registry study * A total of 150 subjects with femoropopliteal artery disease who meet all inclusion and exclusion criteria will be included. * Patients will be followed clinically for 12 months after the procedure. * Duplex ultrasound, CT or catheter-based angiography follow-up according to participating hospital's protocol will be performed at 12 months. * Presence of stent fracture will be evaluated by plain radiography or fluoroscopy at 12 months. * Quality of life by standardized questionnaires (at baseline \& at 1 \& 12 months)
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | innova stent (Boston scientific) |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2021-01-01
- Completion
- 2021-01-01
- First posted
- 2016-03-08
- Last updated
- 2020-09-28
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02701816. Inclusion in this directory is not an endorsement.