- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01746550
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
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
70
Phase
- 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
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Fukuoka, Japan
- Kyushu University Hospital
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Fukuoka
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Kitakyushu, Fukuoka, Japan
- Kokura Kinen
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Hokkaido
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Sapporo, Hokkaido, Japan
- Tokeidai Hospital
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Hyogo
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Amagasaki, Hyogo, Japan
- Kansai Rosai Hospital
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Kanagawa
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Kamakura, Kanagawa, Japan
- Shonankamakura General Hospital
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Yokohama, Kanagawa, Japan
- Saiseikai Yokohamashi Tobu Hospital
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Miyagi
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Sendai, Miyagi, Japan
- Sendai Kousei Hospital
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Nara
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Kashihara, Nara, Japan
- Nara Medical University Hospital
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Osaka
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Kishiwada, Osaka, Japan
- Kishiwada Tokushukai Hospital
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Saitama
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Kasukabe, Saitama, Japan
- Kasukabe Chuo General Hospital
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Tokyo
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Meguro, Tokyo, Japan
- Toho University Ohashi Hospital
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Minato, Tokyo, Japan
- The Jikei University Hospital
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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
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 |
Intervention / Treatment |
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Experimental: MD-12-001 Stent Arm
This study includes a single arm, the MD-12-001 Stent Arm.
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MD-12-001 is a self-expanding nitinol stent
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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The proportion of subjects who are free of target limb failure at 12-months post study procedure.
Time Frame: 12-months post study procedure
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12-months post study procedure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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The proportion of subjects who are free of target limb failure.
Time Frame: 30-days, 6-, 24-, and 36-months post study procedure
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30-days, 6-, 24-, and 36-months post study procedure
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The proportion of subjects with primary target lesion patency.
Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
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This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.
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30-days, 6-, 12-, 24-, and 36-months post study procedure
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The proportion of subjects with secondary target vessel/lesion patency.
Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
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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.
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30-days, 6-, 12-, 24-, and 36-months post study procedure
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Proportion of subjects who achieve acute procedural success.
Time Frame: Perioperative period (period during study procedure)
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Perioperative period (period during study procedure)
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Rutherford category assessment.
Time Frame: Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
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The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.
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Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
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Ankle-brachial index measurements.
Time Frame: Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
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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.
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Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
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Quality of Life (SF-36) Questionnaire
Time Frame: Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
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The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.
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Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
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Proportion of Subjects who experience Major Adverse Events.
Time Frame: 30-days post procedure
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Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.
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30-days post procedure
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Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
Time Frame: through 60-months post study procedure
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through 60-months post study procedure
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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
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12-, 24-, 36-, 48-, and 60-months post study procedure
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Proportion of subjects without stent fracture
Time Frame: 30-days, 6-, 12-, 24, and 36-months post study procedure
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30-days, 6-, 12-, 24, and 36-months post study procedure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- 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
December 1, 2012
Primary Completion (Actual)
October 11, 2014
Study Completion (Actual)
October 1, 2018
Study Registration Dates
First Submitted
December 7, 2012
First Submitted That Met QC Criteria
December 10, 2012
First Posted (Estimate)
December 11, 2012
Study Record Updates
Last Update Posted (Actual)
April 11, 2019
Last Update Submitted That Met QC Criteria
April 10, 2019
Last Verified
April 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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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