Clinical trial NCT02648334: Randomized Comparison of DCB for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease
Official title: Randomized Comparison of Drug-Coated Balloons for the Treatment of Superficial Femoral and Popliteal Peripheral Artery Disease: Prospective, Multicenter, Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Angioplasty, Balloon
Catheterization, Peripheral
Popliteal Artery
Femoral Artery
Keywords: Drug-Coated Balloon
Superficial Femoral artery
popliteal peripheral Artery
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2016-01-07
Enrollment: 443
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: the event rate of composite event
timeFrame: 1 year
Secondary outcomes:
measure: all cause death
timeFrame: 2 years
measure: cardiac death
timeFrame: 2 years
measure: myocardial infarction
timeFrame: 2 years
measure: stroke
timeFrame: 2 years
measure: amputation of target limb
timeFrame: 2 years
measure: target lesion revascularization
timeFrame: 2 years
measure: The change of Rutherford classification
timeFrame: 2 years
measure: The change of ABI(ankle-brachial index) score
timeFrame: 2 years
measure: MACE
timeFrame: 2 years
measure: thrombosis
timeFrame: 2 years
Other outcomes:
Locations:
city: Anyang
country: Korea, Republic of
facility: Hallym University Sacred Heart Hospital
city: Changwon
country: Korea, Republic of
facility: Gyeongsang National University Changwon Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daejeon
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Goyang-si
country: Korea, Republic of
facility: Myongji Hospital
city: Gyeonggi-do
country: Korea, Republic of
facility: Seoul national university Bundang hospital
city: Jeonju
country: Korea, Republic of
facility: Jesushospital
city: Pusan
country: Korea, Republic of
facility: Dong-A Medical Center
city: Pusan
country: Korea, Republic of
facility: Inje University Pusan Paik Hospital
city: Pusan
country: Korea, Republic of
facility: Veterans Hospital
city: Sejong
country: Korea, Republic of
facility: Chungnam National University Sejong Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Veterans Hospital Service Medical Center
Study officials:
References: