Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 9:15 PM
Ignite Modification Date:
2025-12-24 @ 9:15 PM
NCT ID:
NCT03517904
Brief Summary:
* Prospective, randomized, controlled, multi-center study
* A total of 240 subjects with femoropopliteal artery disease will be included according to inclusion and exclusion criteria.
* Patients will be randomized in a 1:1 manner into IVUS-guided or angiography-guided intervention group.
* Second 1:1 randomization into dual antiplatelet therapy (aspirin + clopidogrel) or triple antiplatelet therapy (aspirin + clopidogrel + cilostazol) is optional
* All patients will be treated with drug-coated balloons (In.PACT Admiral) for femoropopliteal lesions.
* Bare metal self-expandable stents will be used in addition according to findings of IVUS or angiography such as severity of arterial dissection or residual stenosis.
* Patients will be followed clinically for 1 year after the procedure.
* Ankle-brachial index and Image study follow-up (Duplex US or CT angiography) will be performed at 1 year.
Study:
NCT03517904
Study Brief:
Protocol Section:
NCT03517904