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LEVANT Japan Clinical Trial

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2013 by C. R. Bard
Sponsor:
Collaborator:
Medicon, Inc.
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01816412
First received: March 19, 2013
Last updated: March 25, 2013
Last verified: March 2013
  Purpose

To demonstrate the safety and efficacy of MD02-LDCB for treatment of stenosis or occlusion of the femoral and popliteal arteries in the Japanese population.


Condition Intervention Phase
Femoral Arterial Stenosis
Stenosis of Popliteal Arteries
Femoral Artery Occlusion
Occlusion of Popliteal Arteries
Device: MD02-LDCB Paclitaxel coated balloon catheter
Procedure: Standard Uncoated Balloon Angioplasty Catheter
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Single Blind, Randomized, Controlled Japanese Population Trial Comparing MD02-LDCB Versus Standard Balloon Angioplasty for Treatment of Femoropopliteal Arteries

Resource links provided by NLM:


Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
    Primary Patency


Secondary Outcome Measures:
  • Safety [ Time Frame: 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Composite of freedom from all-cause peri-operative (≤30 day) death and freedom at 6 months from the following: index limb amputation (above or below the ankle), index limb re-intervention, and index-limb-related death.

  • Efficacy [ Time Frame: 1, 3, 6, 12 and 24 months ] [ Designated as safety issue: No ]
    Primary Patency of the target lesion at 6 months. Primary Patency is defined as the absence of target lesion restenosis (defined by DUS peak systolic velocity ratio (PSVR) ≥2.5) and freedom from target lesion revascularization (TLR).


Estimated Enrollment: 150
Study Start Date: March 2013
Estimated Study Completion Date: February 2016
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LDCB
Paclitaxel Coated Balloon
Device: MD02-LDCB Paclitaxel coated balloon catheter
Active Comparator: PTA
Standard Uncoated Balloon Angioplasty Catheter PTA Catheter
Procedure: Standard Uncoated Balloon Angioplasty Catheter
Other Name: PTA Catheter

Detailed Description:

The study will enroll patients presenting with claudication or ischemic rest pain and an angiographically significant lesion in the superficial femoral or popliteal artery and a patent outflow artery to the foot. After successful protocol-defined pre-dilatation, subjects that are determined not to require stenting based on defined angiographic criteria are randomized 2:1 to treatment with either MD02-LDCB (test arm) or standard PTA catheter (control arm) using similar techniques. Subjects that do not meet post-predilatation lesion criteria are excluded (and treated per standard practice) and followed for safety for 30 days. Randomized subjects will have ultrasound follow-up through 2 years and are consented for up to 2 years clinical follow-up.

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or non-pregnant female ≥20 years of age;
  • Rutherford Clinical Category 2-4;
  • Length ≤15 cm;
  • ≥70% stenosis
  • Lesion location starts ≥1 cm below the common femoral bifurcation and terminates distally ≤2 cm below the tibial plateau AND ≥1 cm above the origin of the TP trunk;
  • A patent inflow artery as confirmed by angiography
  • At least one patent native outflow artery to the ankle

Exclusion Criteria:

  • Life expectancy of < 2 years;
  • History of hemorrhagic stroke within 3 months;
  • Previous or planned surgical or interventional procedure within 2 weeks before or within 30 days after the index procedure;
  • History of MI, thrombolysis or angina within 2 weeks of enrollment;
  • Renal failure or chronic kidney disease
  • Severe calcification that renders the lesion un-dilatable
  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: NCT01816412

Locations
Japan
Kansai Rosai Hospital. Recruiting
Amagasaki-shi, Hyogo-ken., Japan, 3-1-69
Contact: Osamu Iida    06-6416-1221      
Sponsors and Collaborators
C. R. Bard
Medicon, Inc.
Investigators
Principal Investigator: Hiroyoshi Yokoi Kokura Memorial Hospital Cardiovascular Internal Medicine
Principal Investigator: Osamu lida Kansai Rosai Hospital Cardiovascular Internal Medicine
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01816412     History of Changes
Other Study ID Numbers: MD02-LDCB
Study First Received: March 19, 2013
Last Updated: March 25, 2013
Health Authority: Japan: MHLW LEVANT Japan study is conducted according to Declaration of Helsinki, Standards stipulated in Article 14, Paragraph 3 & Article 80-2 of the PAL, and Medical Device GCP Ministerial Ordinance".

Keywords provided by C. R. Bard:
Arms
Experimental
Drug Coated Angioplasty Balloon
Active Comparator
Standard angioplasty balloon

Additional relevant MeSH terms:
Constriction, Pathologic
Pathological Conditions, Anatomical
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 20, 2014