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A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients (Reliable)

Primary Purpose

Arterial Occlusive Disease

Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MD-12-001 Stent
Sponsored by
C. R. Bard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Arterial Occlusive Disease

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest).
  • The target lesion(s) has evidence of narrowing or blockage and can be stented.
  • The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm.
  • The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm

Key Exclusion Criteria:

  • The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum)
  • The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines)
  • The subject has a history of bleeding disorders (diatheses or coagulopathy).
  • The subject has kidney failure or is having dialysis treatment.
  • The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots.
  • Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb).
  • Subject has a history of bypass surgery on the study vessel.
  • Subject has a history of heart attack or stroke within 6 months of study procedure.
  • The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response).
  • The subject is diagnosed with a severe infection (septicemia).
  • Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft.
  • The subject with a stent previously implanted into the target vessel.
  • Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days.
  • Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial.
  • The subject is participating in an investigational drug or another investigational device study.
  • Subject has a large amount of blood clot next to the study lesion.

Sites / Locations

  • Kokura Kinen
  • Tokeidai Hospital
  • Kansai Rosai Hospital
  • Shonankamakura General Hospital
  • Saiseikai Yokohamashi Tobu Hospital
  • Sendai Kousei Hospital
  • Nara Medical University Hospital
  • Kishiwada Tokushukai Hospital
  • Kasukabe Chuo General Hospital
  • Toho University Ohashi Hospital
  • The Jikei University Hospital
  • Kyushu University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MD-12-001 Stent Arm

Arm Description

This study includes a single arm, the MD-12-001 Stent Arm.

Outcomes

Primary Outcome Measures

The proportion of subjects who are free of target limb failure at 12-months post study procedure.

Secondary Outcome Measures

The proportion of subjects who are free of target limb failure.
The proportion of subjects with primary target lesion patency.
This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.
The proportion of subjects with secondary target vessel/lesion patency.
This endpoint will assess whether the study blockage has shut again; where the target vessel/lesion no longer has blood flow or where surgical bypass of the vessel is performed.
Proportion of subjects who achieve acute procedural success.
Rutherford category assessment.
The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.
Ankle-brachial index measurements.
The ratio of blood pressure in the lower legs to the blood pressure in the arms will be calculated and assessed as a measure of disease severity.
Quality of Life (SF-36) Questionnaire
The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.
Proportion of Subjects who experience Major Adverse Events.
Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.
Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)
Proportion of subjects without stent fracture

Full Information

First Posted
December 7, 2012
Last Updated
April 10, 2019
Sponsor
C. R. Bard
Collaborators
Medicon, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01746550
Brief Title
A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients
Acronym
Reliable
Official Title
A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
October 11, 2014 (Actual)
Study Completion Date
October 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
C. R. Bard
Collaborators
Medicon, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to assess the safety and effectiveness of the MD-12-001 stent in the treatment of superficial femoral artery and proximal popliteal artery blockages in Japanese patients.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arterial Occlusive Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MD-12-001 Stent Arm
Arm Type
Experimental
Arm Description
This study includes a single arm, the MD-12-001 Stent Arm.
Intervention Type
Device
Intervention Name(s)
MD-12-001 Stent
Other Intervention Name(s)
Bard Lifestent Vascular Stent
Intervention Description
MD-12-001 is a self-expanding nitinol stent
Primary Outcome Measure Information:
Title
The proportion of subjects who are free of target limb failure at 12-months post study procedure.
Time Frame
12-months post study procedure
Secondary Outcome Measure Information:
Title
The proportion of subjects who are free of target limb failure.
Time Frame
30-days, 6-, 24-, and 36-months post study procedure
Title
The proportion of subjects with primary target lesion patency.
Description
This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.
Time Frame
30-days, 6-, 12-, 24-, and 36-months post study procedure
Title
The proportion of subjects with secondary target vessel/lesion patency.
Description
This endpoint will assess whether the study blockage has shut again; where the target vessel/lesion no longer has blood flow or where surgical bypass of the vessel is performed.
Time Frame
30-days, 6-, 12-, 24-, and 36-months post study procedure
Title
Proportion of subjects who achieve acute procedural success.
Time Frame
Perioperative period (period during study procedure)
Title
Rutherford category assessment.
Description
The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.
Time Frame
Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
Title
Ankle-brachial index measurements.
Description
The ratio of blood pressure in the lower legs to the blood pressure in the arms will be calculated and assessed as a measure of disease severity.
Time Frame
Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Title
Quality of Life (SF-36) Questionnaire
Description
The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.
Time Frame
Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Title
Proportion of Subjects who experience Major Adverse Events.
Description
Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.
Time Frame
30-days post procedure
Title
Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
Time Frame
through 60-months post study procedure
Title
The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)
Time Frame
12-, 24-, 36-, 48-, and 60-months post study procedure
Title
Proportion of subjects without stent fracture
Time Frame
30-days, 6-, 12-, 24, and 36-months post study procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Rutherford Category 2-4 (mild intermittent claudication (pain while walking)to ischemic pain (pain due to decreased blood flow) at rest). The target lesion(s) has evidence of narrowing or blockage and can be stented. The total length of the lesion or series of lesions is estimated to be less than or equal to 150 mm. The target vessel reference diameter is greater than or equal to 4.0 mm and less than or equal to 6.5 mm Key Exclusion Criteria: The subject has a known reaction (including allergic reaction) or sensitivity to blood thinning medications, or study device materials (nickel, titanium or tantalum) The subject has a known sensitivity to medical imaging substances (contract media) that cannot be pretreated with medications (steroids or/and antihistamines) The subject has a history of bleeding disorders (diatheses or coagulopathy). The subject has kidney failure or is having dialysis treatment. The subject has insufficient liver function, swelling of vein(s) caused by blood clot (thrombophlebitis), uremia, systemic lupus, or deep vein blood clots. Subject has Acute Limb Ischemia (a sudden loss of blood flow to the limb). Subject has a history of bypass surgery on the study vessel. Subject has a history of heart attack or stroke within 6 months of study procedure. The subject is receiving immunosuppressive therapy (medications that lower the body's normal immune response). The subject is diagnosed with a severe infection (septicemia). Principal investigator determines the subject's condition would prevent the subject from undergoing the study procedure or cannot support a vascular bypass graft. The subject with a stent previously implanted into the target vessel. Subject has disease in both legs where both limbs meet the inclusion criteria and it is planned to treat both limbs within 30 days. Pregnant, possibly pregnant and/or nursing female subjects are excluded, as are female subjects who are willing to have a baby during the trial. The subject is participating in an investigational drug or another investigational device study. Subject has a large amount of blood clot next to the study lesion.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Masato Nakamura
Organizational Affiliation
Toho University Ohashi Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kokura Kinen
City
Kitakyushu
State/Province
Fukuoka
Country
Japan
Facility Name
Tokeidai Hospital
City
Sapporo
State/Province
Hokkaido
Country
Japan
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
Facility Name
Shonankamakura General Hospital
City
Kamakura
State/Province
Kanagawa
Country
Japan
Facility Name
Saiseikai Yokohamashi Tobu Hospital
City
Yokohama
State/Province
Kanagawa
Country
Japan
Facility Name
Sendai Kousei Hospital
City
Sendai
State/Province
Miyagi
Country
Japan
Facility Name
Nara Medical University Hospital
City
Kashihara
State/Province
Nara
Country
Japan
Facility Name
Kishiwada Tokushukai Hospital
City
Kishiwada
State/Province
Osaka
Country
Japan
Facility Name
Kasukabe Chuo General Hospital
City
Kasukabe
State/Province
Saitama
Country
Japan
Facility Name
Toho University Ohashi Hospital
City
Meguro
State/Province
Tokyo
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato
State/Province
Tokyo
Country
Japan
Facility Name
Kyushu University Hospital
City
Fukuoka
Country
Japan

12. IPD Sharing Statement

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A Safety and Effectiveness Study of the MD-12-001 Stent in the Treatment of Superficial Femoral Artery or Popliteal Artery Blockages in Japanese Patients

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