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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by Acotec Scientific Co., Ltd
Sponsor:
Information provided by (Responsible Party):
Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier:
NCT01850056
First received: April 27, 2013
Last updated: May 5, 2014
Last verified: March 2013
  Purpose

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


Condition Intervention
Peripheral Artery Disease
Device: drug eluting balloon catheter (trade name: Orchid)
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)

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

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Late Lumen Loss [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measure difference of the MLD(minimal lumen diameter) at 0 time and 6 months


Secondary Outcome Measures:
  • Minimal lumen diameter (MLD) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    measure minimal lumen diameter (MLD) of target lesion

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

  • target lesion revascularization [ Time Frame: 6 months, 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    target lesion revascularization is defined as any reintervention of artery bypass graft surgery involving the target lesion

  • change in Rutherford stage [ 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

  • change in ankle brachial index(ABI) [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    change in ankle brachial index(ABI) compared to pretreatment

  • major amputation [ 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)

  • Death [ Time Frame: 12 months, 18 months, 24 months ] [ Designated as safety issue: No ]
    death of any cause


Estimated Enrollment: 200
Study Start Date: April 2013
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: August 2015 (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 superficial femoral artery(SFA) and/or popliteal artery
Device: drug eluting balloon catheter (trade name: Orchid)
Other Name: drug eluting dilation catheter
Active Comparator: common balloon catheter(uncoated drug)
use common balloon catheter to inflate stenosis or occlusion in SFA and/or popliteal artery
Device: common percutaneous transluminal angioplasty balloon catheter (trade name: Admiral)
Other Name: common PTA catheter

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age between 18 and 80 years
  • Patients with peripheral artery disease (PAD), with Rutherford classification between 2 and 5
  • an occlusion or a minimum grade of stenosisPrimary over 70% in the superficial femoral artery an /or the popliteal artery
  • Total length of treat lesion(s)is less or equal to 40cm
  • signed Patient informed consent form

Exclusion Criteria:

  • plasma Cr level greater than 150 umol/L 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
  • target lesion can't be cross by the guide wire
  • distal outflow through less than one lower leg vessel
  • known hypersensitivity to aspirin, heparin, clopidogrel,paclitaxel, contrast medium, etc.
  • patients participating in another clinical trials with interfere with this trial in the past 3 months
  • pregnancy and lactating woman
  • untreatable bleeding diatheses
  • other diseases, such as cancer, liver disease, or cardiac insufficiency, which may lead to protocol violations or markedly shorten a patients's life expectancy(less than 2 years)
  • patients unable or unwilling to participate this trial
  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: NCT01850056

Locations
China
Wei Guo Recruiting
Beijing, China, 100853
Contact: Wei Guo, Dr       pla301dml@vip.sina.com   
Sponsors and Collaborators
Acotec Scientific Co., Ltd
  More Information

No publications provided

Responsible Party: Acotec Scientific Co., Ltd
ClinicalTrials.gov Identifier: NCT01850056     History of Changes
Other Study ID Numbers: acotec-02
Study First Received: April 27, 2013
Last Updated: May 5, 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 September 16, 2014