Effectiveness and Safety Study of Drug Eluting Balloon(DEB) in Percutaneous Transluminal Angioplasty(PTA) Procedure of the Infrapopliteal Artery

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by Acotec Scientific Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier:
NCT02137577
First received: May 5, 2014
Last updated: May 12, 2014
Last verified: December 2013
  Purpose

The purpose of this study is to determine whether DEB is more effective than common PTA balloon using under in long-term vessel patency and inhibiting restenosis in the infrapopliteal artery.


Condition Intervention
Peripheral Artery Disease
Device: drug eluting balloon catheter (trade name: Lotus/Tulip)
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Amphirion DEEP)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Prospective, Multi-center and Randomized Controlled Clinical Study to Verify Effectiveness and Safety of Drug-eluting Balloon in PTA Procedure of the Infrapopliteal Artery

Resource links provided by NLM:


Further study details as provided by Acotec Scientific Co., Ltd:

Primary Outcome Measures:
  • Change from baseline Restenosis rate of target vessel at 6 months, 12months, 18months, 24months [ Time Frame: 6 months, 12 months, 18 months, 24months ] [ Designated as safety issue: No ]
    stenosis over 50% is defined as restenosis


Secondary Outcome Measures:
  • device success rate [ Time Frame: during the operation(after using the DEB catheter) ] [ Designated as safety issue: No ]
    DEB catheter can reach the target lesions, expand as expected(not broken), and withdraw successfully.

  • technical success rates [ Time Frame: during the operation(after using the DEB catheter) ] [ Designated as safety issue: No ]
    The blood supply of the target lesion recovered after treatment, and residual stenosis less than 50%

  • operation success rate [ Time Frame: during the operation(after using the DEB catheter) ] [ Designated as safety issue: No ]
    both device succeed and technical succeed, and without clinical complication

  • if occured clinically driven TLR( target lesion revascularization) at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    Clinically driven TLR is defined as revascularization performed on a patient who returns with clinical symptoms such as: resting pain occur again, ulcer deterioration, new foot ulcers

  • if occured major amputation at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    major amputation at the index limb(major amputation is defined as an amputation above the foot)

  • Ulcer healing rate [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Change from baseline ABI(ankle brachial index) at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    measure ankle brachial index

  • change from baseline Rutherford stage at 6 months, 12 months, 18 months, 24 months [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]

    based the following definition of Rutherford stage, evaluate the stage of patient. Then compare the stage of patient just after procedure and 6 months after treatment

    Stage clinical symptom

    0 asymptomatic

    1. mild claudication
    2. moderate claudication
    3. severe claudication
    4. ischemic rest pain
    5. minor tissue loss
    6. ulceration or gangrene


Estimated Enrollment: 180
Study Start Date: May 2014
Estimated Study Completion Date: November 2016
Estimated Primary Completion Date: August 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: drug eluting balloon catheter
use drug eluting balloon catheter to inflate the stenosis or occlusion in below popliteal artery
Device: drug eluting balloon catheter (trade name: Lotus/Tulip)
drug eluting dilation catheter
Active Comparator: common balloon catheter(uncoated drug)
use common balloon catheter to inflate stenosis or occlusion in below popliteal artery
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Amphirion DEEP)
common PTA catheter

  Eligibility

Ages Eligible for Study:   18 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 85 years
  • Patients with peripheral artery disease (PAD), with Rutherford classification between 4 and 6
  • an occlusion or a minimum grade of stenosis Primary over 70% in the below popliteal artery
  • The expected survival time is more than 1 year
  • signed Patient informed consent form

Exclusion Criteria:

  • Serum creatinine clearance rate less than 30ml/min in patients
  • patients with acute thrombosis requiring lysis or thrombectomy
  • patient with a lysis or an lower limb intervention as a therapy within the last 6 weeks
  • patient requiring intervention in both lower limbs at the same time
  • In-stent restenosis in the blow-knee popliteal artery
  • target lesion can't be cross by the guide wire
  • the stenosis rate of proximal outflow more than 30% with or without intervention
  • the length of the stenosis or occlusion in proximal outflow(including the Iliac artery, the superficial femoral artery, the Popliteal artery) more than 150mm before intervention
  • stenosis or occlusion of distal outflow for below-the-ankle artery.
  • expected major amputations at the index limb before intervention
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • patients participating in another clinical trials with interfere with this trial in the same time
  • pregnancy and lactating woman
  • untreatable bleeding diatheses
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02137577

Locations
China
People's Liberation Army General Hospital Recruiting
BeiJing, China, 100853
Contact: Wei Guo    +10 86 66936336    hindley007@163.com   
Sponsors and Collaborators
Acotec Scientific Co., Ltd
  More Information

No publications provided

Responsible Party: Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier: NCT02137577     History of Changes
Other Study ID Numbers: acotec-03
Study First Received: May 5, 2014
Last Updated: May 12, 2014
Health Authority: China: Food and Drug Administration

Keywords provided by Acotec Scientific Co., Ltd:
drug eluting balloon catheter

Additional relevant MeSH terms:
Peripheral Arterial Disease
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on July 22, 2014