Korean Multicenter Registry of EPIC Stent for Iliac Artery Disease: (K-EPIC Registry)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02698358|
Recruitment Status : Active, not recruiting
First Posted : March 3, 2016
Last Update Posted : January 29, 2019
- Prospective, single-arm, multi-center registry study
- A total of 150 subjects with iliac 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)
|Condition or disease||Intervention/treatment|
|Iliac Artery Disease||Device: Epic stent (Boston Scientific)|
|Study Type :||Observational|
|Actual Enrollment :||68 participants|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
Patients with femoropopliteal artery disease undergoing endovascular therapy using Epic stent (Boston Scientific).
Device: Epic stent (Boston Scientific)
- Primary patency [ Time Frame: 12 months ]Absence of restenosis >50% based on an imaging study (Duplex ultrasound, CT angiography or catheter angiography) at 12 months
- Target lesion revascularization rate [ Time Frame: 12 months ]
- Stent fracture rate [ Time Frame: 12 months ]
- Quality of life by standardized questionnaires [ Time Frame: 12 months ]
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): NCT02698358
|Korea, Republic of|
|Seoul, Korea, Republic of, 120-752|