Korean Multicenter Prospective Registry of In.PACT DEB for Isolated Popliteal Artery Disease (K-POP Study)
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|ClinicalTrials.gov Identifier: NCT02698345|
Recruitment Status : Recruiting
First Posted : March 3, 2016
Last Update Posted : January 18, 2019
- 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.
|Condition or disease||Intervention/treatment|
|Popliteal Artery Disease||Device: drug-eluting balloon (In.PACT Admiral, Medtronic)|
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||March 2021|
|Estimated Study Completion Date :||March 2021|
Patients with isolated popliteal artery disease undergoing endovascular therapy using drug-eluting balloon (In.PACT Admiral, Medtronic)
Device: drug-eluting balloon (In.PACT Admiral, Medtronic)
- Primary patency rate [ Time Frame: 12 months after the index procedure ]absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
- Target vessel revascularization rate [ Time Frame: 12 months ]frequency of repeat intervention or surgical treatment due to loss of patency at the target vessel
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02698345