Trials / Unknown
UnknownNCT02698345
Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
- Status
- Unknown
- Phase
- —
- Study type
- Observational
- Enrollment
- 100 (estimated)
- Sponsor
- Yonsei University · Academic / Other
- Sex
- All
- Age
- 19 Years – 85 Years
- Healthy volunteers
- Not accepted
Summary
* Prospective, multi-center, single-arm registry study * A total of 100 subjects with isolated popliteal artery lesions according to inclusion and exclusion criteria will be enrolled. * All popliteal artery lesions will be treated with drug-eluting balloon (In.PACT Admiral, Medtronic). • Atherectomy or use of bare nitinol stent in combination with drug-eluting balloon is allowed • Patients will be followed clinically for 12 months after the procedure. * Imaging study (Duplex ultrasound, CT angiography or catheter angiography) follow-up will be performed at 12 months.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | drug-eluting balloon (In.PACT Admiral, Medtronic) |
Timeline
- Start date
- 2016-01-01
- Primary completion
- 2021-03-01
- Completion
- 2021-03-01
- First posted
- 2016-03-03
- Last updated
- 2019-01-18
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT02698345. Inclusion in this directory is not an endorsement.