Clinical trial NCT02772224: Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease
Official title: The Efficacy and Safety of Paclitaxel-eluting Balloons for the Treatment of Below the Knee Peripheral Arterial Disease as Compared to Conventional Balloon Angioplasty: a Randomized Controlled Clinical Trial.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE1
Conditions: Peripheral Arterial Disease
Lead sponsor: Shanghai 10th People's Hospital
Sponsor class: OTHER
First posted: 2016-05-13
Enrollment: 180
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Comparing the efficacy and safety of drug-eluting balloons (DEB) for the treatment of below-the-knee peripheral arterial occlusive disease with conventional balloon angioplasty (BA).

Detailed description: Over the past decade, percutaneous transluminal angioplasty (PTA) has established its position in the treatment of below the knee arterial occlusive disease with intermittent claudication and/or critical limb ischemia. However, the efficacy of percutaneous transluminal angioplasty (PTA) with conventional balloons, is limited by the high 12-month restenosis and target lesion revascularization (TLR) rates. Local delivery of newer anti-proliferative drug via drug-eluting balloons (DEBs) has recently shown promising results in the treatment of femoropopliteal disease, and in the BTK area, a reduction in 3-month binary restenosis has been observed compared with historical controls treated with PTA. Drug eluting balloon has three potential advantages: (1) homogenous drug transfer to the vessel wall; (2) highest drug concentrations at the vessel wall at the time of injury; and (3) absence of a stent or delivery polymer.

This study sought to investigate the long-term efficacy and safety of new drug (Paclitaxel)-eluting balloons (DEB) for the treatment of below the knee peripheral arterial disease.

Eligibility criteria: Inclusion Criteria:

1. Patients with Peripheral vascular disease with or without diabetes.
2. Rutherford class 2-6.
3. Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
4. Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
5. Written informed consent signed by the patients or representatives

Exclusion Criteria:

1. Previous bypass surgery or stent placement at the ipsilateral lower limb
2. History of intolerance to antiplatelet therapy, heparin, or contrast media.
3. Bleeding diathesis;
4. Active systemic bacterial infection;
5. Severely impaired renal function (serum creatinine level \> 2.5 mg/dL.
6. Expected survival time of less than 24 months

Primary outcomes:
measure: Restenosis rate
timeFrame: 12 months
measure: Peak systolic velocity ratio
timeFrame: 12 months
Secondary outcomes:
measure: Rutherford scale
timeFrame: Immediately after procedure
measure: ABI value
timeFrame: Immediately after procedure
measure: Residual stenosis
timeFrame: Immediately after procedure
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Shanghai Tenth people's hospital, Tongji university
state: Shanghai
Study officials:
References:
citation: Liistro F, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.
citation: Karnabatidis D, Spiliopoulos S, Katsanos K, Siablis D. Below-the-knee drug-eluting stents and drug-coated balloons. Expert Rev Med Devices. 2012 Jan;9(1):85-94. doi: 10.1586/erd.11.67.
citation: Jens S, Conijn AP, Koelemay MJ, Bipat S, Reekers JA. Randomized trials for endovascular treatment of infrainguinal arterial disease: systematic review and meta-analysis (Part 2: Below the knee). Eur J Vasc Endovasc Surg. 2014 May;47(5):536-44. doi: 10.1016/j.ejvs.2014.02.012. Epub 2014 Mar 17.
citation: Schnorr B, Albrecht T. Drug-coated balloons and their place in treating peripheral arterial disease. Expert Rev Med Devices. 2013 Jan;10(1):105-14. doi: 10.1586/erd.12.67.
citation: Zeller T, Baumgartner I, Scheinert D, Brodmann M, Bosiers M, Micari A, Peeters P, Vermassen F, Landini M; IN.PACT DEEP Trial Investigators. IN.PACT Amphirion paclitaxel eluting balloon versus standard percutaneous transluminal angioplasty for infrapopliteal revascularization of critical limb ischemia: rationale and protocol for an ongoing randomized controlled trial. Trials. 2014 Feb 19;15:63. doi: 10.1186/1745-6215-15-63.