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)

April 10, 2019 updated by: C. R. Bard

A Single Arm Clinical Trial in Japan for Reconstruction of Obstructive Lesions of the Superficial Femoral Artery or Proximal Popliteal Artery by Bard LifeStent.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
70

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Fukuoka, Japan
        • Kyushu University Hospital
    • Fukuoka
      • Kitakyushu, Fukuoka, Japan
        • Kokura Kinen
    • Hokkaido
      • Sapporo, Hokkaido, Japan
        • Tokeidai Hospital
    • Hyogo
      • Amagasaki, Hyogo, Japan
        • Kansai Rosai Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan
        • Shonankamakura General Hospital
      • Yokohama, Kanagawa, Japan
        • Saiseikai Yokohamashi Tobu Hospital
    • Miyagi
      • Sendai, Miyagi, Japan
        • Sendai Kousei Hospital
    • Nara
      • Kashihara, Nara, Japan
        • Nara Medical University Hospital
    • Osaka
      • Kishiwada, Osaka, Japan
        • Kishiwada Tokushukai Hospital
    • Saitama
      • Kasukabe, Saitama, Japan
        • Kasukabe Chuo General Hospital
    • Tokyo
      • Meguro, Tokyo, Japan
        • Toho University Ohashi Hospital
      • Minato, Tokyo, Japan
        • The Jikei University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MD-12-001 Stent Arm
This study includes a single arm, the MD-12-001 Stent Arm.
Device: MD-12-001 Stent
MD-12-001 is a self-expanding nitinol stent
Other Names:
  • Bard Lifestent Vascular Stent

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
The proportion of subjects who are free of target limb failure at 12-months post study procedure.
Time Frame: 12-months post study procedure
12-months post study procedure

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The proportion of subjects who are free of target limb failure.
Time Frame: 30-days, 6-, 24-, and 36-months post study procedure
30-days, 6-, 24-, and 36-months post study procedure
The proportion of subjects with primary target lesion patency.
Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.
30-days, 6-, 12-, 24-, and 36-months post study procedure
The proportion of subjects with secondary target vessel/lesion patency.
Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
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.
30-days, 6-, 12-, 24-, and 36-months post study procedure
Proportion of subjects who achieve acute procedural success.
Time Frame: Perioperative period (period during study procedure)
Perioperative period (period during study procedure)
Rutherford category assessment.
Time Frame: Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.
Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
Ankle-brachial index measurements.
Time Frame: Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
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.
Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Quality of Life (SF-36) Questionnaire
Time Frame: Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.
Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Proportion of Subjects who experience Major Adverse Events.
Time Frame: 30-days post procedure
Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.
30-days post procedure
Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
Time Frame: through 60-months post study procedure
through 60-months post study procedure
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
12-, 24-, 36-, 48-, and 60-months post study procedure
Proportion of subjects without stent fracture
Time Frame: 30-days, 6-, 12-, 24, and 36-months post study procedure
30-days, 6-, 12-, 24, and 36-months post study procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
C. R. Bard

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medicon, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Masato Nakamura, Toho University Ohashi Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 11, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 7, 2012

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 10, 2012

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 11, 2012

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 11, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 10, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MED-12-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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