Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease

Catheterization, Peripheral Clinical Trial

— DCB-SFA  

Official title:

Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02648334
• Other study ID #: AMCCV2015-08
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 10, 2016
• Est. completion date: December 2027

Study information

• Verified date: November 2023
• Source: Asan Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates the safety and effectiveness Percutaneous Transluminal Angioplasty(PTA) using Drug-Coated Balloons for the treatment of Superficial Femoral and popliteal peripheral Artery disease.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1080
• Est. completion date: December 2027
• Est. primary completion date: September 5, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Age 19 and above

• Subject with claudication or critical limb ischemia(Rutherford classification level 2~5)

• Subject with total occlusion or stenosis =70%(de novo, restenosis)

• Vessel diameter 4~6mm

• Success to guide wire pass

• Patients who don't have known hypersensitivity or allergy for dual-platelets

• Willing and able to provide informed written consent

Exclusion Criteria:

• Acute stage

• Acute thrombosis in target limb or target vessel

• Failure to guide wire pass

• Distal outflow

• Lesion with poor inflow

• Life expectancy = 2 years

• Allergic to paclitaxel

• Pregnant or breast feeding woman or disagree with contraception or having children

Related Conditions & MeSH terms

• Angioplasty, Balloon
• Catheterization, Peripheral
• Femoral Artery
• Peripheral Arterial Disease
• Popliteal Artery

Intervention

Device:
• IN.PACT drug coated balloon

• Lutonix drug coated balloon

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	Gyeongsang National University Changwon Hospital	Changwon
Korea, Republic of	Kangwon National University Hospital	Chuncheon
Korea, Republic of	Chungnam National University Hospital	Daejeon
Korea, Republic of	Myongji Hospital	Goyang-si
Korea, Republic of	Seoul national university Bundang hospital	Gyeonggi-do
Korea, Republic of	Jesushospital	Jeonju
Korea, Republic of	Dong-A Medical Center	Pusan
Korea, Republic of	Inje University Pusan Paik Hospital	Pusan
Korea, Republic of	Veterans Hospital	Pusan
Korea, Republic of	Chungnam National University Sejong Hospital	Sejong
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Kangbuk Samsung Medical Center	Seoul
Korea, Republic of	Veterans Hospital Service Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seung-Whan Lee, M.D., Ph.D.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the event rate of composite event	all cause death, revascularization due to amputation or clinical evidence	1 year
Secondary	all cause death		2 years
Secondary	cardiac death		2 years
Secondary	myocardial infarction		2 years
Secondary	stroke		2 years
Secondary	amputation of target limb		2 years
Secondary	target lesion revascularization		2 years
Secondary	The change of Rutherford classification		2 years
Secondary	The change of ABI(ankle-brachial index) score		2 years
Secondary	MACE	major adverse cardiac event(death, myocardial infarction, stroke)	2 years
Secondary	thrombosis		2 years