Efficacy and Safety of Paclitaxel-eluting Balloons for Below the Knee Peripheral Arterial Disease

Peripheral Arterial Disease Clinical Trial

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02772224
• Other study ID #: 425008534
• Status: Not yet recruiting
• Phase: Phase 1
• First received: May 8, 2016
• Last updated: May 11, 2016
• Start date: June 2016
• Est. completion date: September 2017

Study information

• Verified date: May 2016
• Source: Shanghai 10th People's Hospital
• Contact: Maoquan Li, Ph.D
• Phone: 02166313506
• Email: cjr.limaoquan[@]vip.163.com
• Is FDA regulated: No
• Health authority: China: Ministry of Health
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: September 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Drug eluting balloon angioplasty
In the DEB group, the guide wire will be passed through the occluded or stenosed lumen and the predilatation of the target lesion with standard balloon(s) will be performed before dilatation with a paclitaxel-eluting balloon of the diameter, at least about that of the pre-dilatation balloon (Arteryguard, Rientech, Dezhou, China). The drug eluting balloons will then be inflated according to the manufacturer recommendations. The patients will then be followed every six months for a year to compare its treatment efficacy and safety with that of conventional balloon angioplasty group.
• Conventional balloon angioplasty
The guide wire will be passed through the occluded or stenosed lumen and the conventional balloons will be inflated as recommended by the manufacturer. The primary and secondary outcome will then be assessed and compared with DEB group, on follow up at six and 12 months.

Locations

Country	Name	City	State
China	Shanghai Tenth people's hospital, Tongji university	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai 10th People's Hospital

Country where clinical trial is conducted

China, 

References & Publications (5)

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: 10.101 — View 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. Review. — View 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 p — View 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. Review. — View 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 infrapoplite — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Restenosis rate	The primary study endpoint was the occurrence of > 50% of restenosis in the treated vessel after 12 months as assessed by digital substraction angiography (DSA).	12 months	Yes
Primary	Peak systolic velocity ratio	Peak systolic velocity ratio = 2.4 by Doppler's ultrasonography was the end point of the study for the patient who did not undergo angiography after 12 months.	12 months	Yes
Secondary	Rutherford scale	Clinical success is to be defined as an improvement in Rutherford scale of at least one category after the procedure.	Immediately after procedure	Yes
Secondary	ABI value	Hemodynamic success is to be defined as an improvement of ABI value by = 0.1 after the procedure and lack of deterioration > 0.15 in relation to the maximal value recorded before the procedure.	Immediately after procedure	Yes
Secondary	Residual stenosis	The technical success of the procedure is to be defined as PTA of a lesion with >30 % residual stenosis and lack of flow rate-limiting dissection immediately after treatment.	Immediately after procedure	Yes