Comparison of Intravascular Ultrasound-Guided vs. Angiography-guided Angioplasty and Dual-antiplatelet v. Triple-antiplatelet Therapy for Outcomes of Drug-coated Balloon in the Treatment of Femoropopliteal Artery Disease (IVUS-DCB)
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|ClinicalTrials.gov Identifier: NCT03517904|
Recruitment Status : Recruiting
First Posted : May 8, 2018
Last Update Posted : January 10, 2019
- 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.
|Condition or disease||Intervention/treatment||Phase|
|Femoropopliteal Artery Disease||Procedure: IVUS-guided angioplasty Procedure: Angiography-guided angioplasty||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||May 2016|
|Estimated Primary Completion Date :||February 2021|
|Estimated Study Completion Date :||February 2021|
Experimental: IVUS-guided group
Intravascular ultrasound-guided intervention group
Procedure: IVUS-guided angioplasty
Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. IVUS evaluation will be performed before predilation and after DEB treatment. In cases of stent implantation, additional IVUS evaluation will be performed after stenting. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of IVUS measurement. Implantation of stents will be left to the operator's decision after reviewing IVUS findings after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
Active Comparator: Angiography-guided group
Angiography-guided intervention group
Procedure: Angiography-guided angioplasty
Angioplasty using drug-coated balloon (DCB) will be performed in standard manner. All lesions will be predilated using a plain balloon with a diameter 1 mm smaller than vessel size. Selection of DCB diameter will be chosen on the basis of angiogram. Implantation of stents will be left to the operator's decision after reviewing the angiogram after the DCB treatment. Generally, in presence of ≥ 50% residual stenosis or flow limiting dissections, implantation of stents is recommended.
- Procedures lesion stenosis degree [ Time Frame: at 12 months ]Absence of restenosis >50% by Duplex ultrasound, CT angiography, or catheter-based angiography
- Survival free from target vessel revascularization [ Time Frame: 12 months ]Survival free from 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): NCT03517904
|Korea, Republic of|
|Division of Cardiology, Severance Cardiovascular Hospital, Yonsei University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 120-752|
|Contact: YoungGuk Ko, MD 82-2-2228-8460 firstname.lastname@example.org|