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. 2016 Aug 4;2016(8):CD011319. doi: 10.1002/14651858.CD011319.pub2

AcoArt I.

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:
  • Late lumen loss at 6 months


Secondary:
  • Change in minimal lumen diameter

  • Target vessel restenosis

  • TLR

  • Change in Rutherford classification

  • Change in ABI

  • Major amputation

  • Death

Starting date April 2013
Contact information Acotec Scientific Company, China
Notes Sponsor: Acotec Scientific Company