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

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ClinicalTrials.gov Identifier: NCT02772224
Recruitment Status : Unknown
Verified May 2016 by Maoquan Li, Shanghai 10th People's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2016
Last Update Posted : May 13, 2016
Sponsor:
Information provided by (Responsible Party):
Maoquan Li, Shanghai 10th People's Hospital

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).

Condition or disease Intervention/treatment Phase
Peripheral Arterial Disease Device: Drug eluting balloon angioplasty Device: Conventional balloon angioplasty Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 180 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : June 2016
Estimated Primary Completion Date : September 2016
Estimated Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

Drug Information available for: Paclitaxel

Arm Intervention/treatment
Experimental: Drug eluting balloon angioplasty
Paclitaxel coated balloon angioplasty
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.

Active Comparator: Conventional balloon angioplasty
Conventional balloon angioplasty
Device: 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.




Primary Outcome Measures :
  1. Restenosis rate [ Time Frame: 12 months ]
    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).

  2. Peak systolic velocity ratio [ Time Frame: 12 months ]
    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.


Secondary Outcome Measures :
  1. Rutherford scale [ Time Frame: Immediately after procedure ]
    Clinical success is to be defined as an improvement in Rutherford scale of at least one category after the procedure.

  2. ABI value [ Time Frame: Immediately after procedure ]
    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.

  3. Residual stenosis [ Time Frame: Immediately after procedure ]
    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.



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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02772224


Contacts
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Contact: Maoquan Li, Ph.D 02166313506 cjr.limaoquan@vip.163.com

Locations
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China, Shanghai
Shanghai Tenth people's hospital, Tongji university
Shanghai, Shanghai, China, 200072
Sponsors and Collaborators
Shanghai 10th People's Hospital
Publications of Results:
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Responsible Party: Maoquan Li, Prof. Dr.Li, Shanghai 10th People's Hospital
ClinicalTrials.gov Identifier: NCT02772224    
Other Study ID Numbers: 425008534
First Posted: May 13, 2016    Key Record Dates
Last Update Posted: May 13, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Peripheral Vascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases