Trial name or title |
Prospective, Multi‐center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug‐Eluting Balloon in PTA Procedure (AcoArt I Study) |
Methods |
Randomized controlled trial |
Participants |
Country: China Setting: 7 hospitals Number of participants: 200 Inclusion criteria:
Age 18 to 80 years
Have PAD, with Rutherford classification between 2 and 5
An occlusion or a minimum grade of stenosis > 70% in the SFA, PA, or both
Total length of treat lesion(s) ≤ 40 cm
Signed informed consent form
Exclusion criteria:
Plasma creatinine > 150 µmol/L
Acute thrombosis requiring lysis or thrombectomy
Lysis or any lower limb intervention as a therapy within the last 6 weeks
Requiring intervention in both lower limbs at the same time
Target lesion cannot be crossed by the guidewire
Distal outflow through less than one lower leg vessel.
Known hypersensitivity to acetylsalicylic acid (aspirin), heparin, clopidogrel, paclitaxel, or contrast medium
Participating in another clinical trial with interfere with this trial in the past 3 months
Pregnancy and lactating woman
Untreatable bleeding diseases
Other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a person's life expectancy (< 2 years)
Unable or unwilling to participate in trial
|
Interventions |
Uncoated balloon angioplasty device: Orchid catheter DEB device: Admiral catheter Vessels treated: femoropopliteal vessels |
Outcomes |
Primary:
Secondary:
|
Starting date |
April 2013 |
Contact information |
Acotec Scientific Company, China |
Notes |
Sponsor: Acotec Scientific Company |