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
Device: MD-12-001 Stent
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01746550
Ages eligible for Study
20 Years and older
Genders eligible for Study
Accepts Healthy Volunteers
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
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.
All locations for NCT01746550
Kitakyushu, Fukuoka, Japan
Sapporo, Hokkaido, Japan
Kansai Rosai Hospital
Amagasaki, Hyogo, Japan
Shonankamakura General Hospital
Kamakura, Kanagawa, Japan
Saiseikai Yokohamashi Tobu Hospital
Yokohama, Kanagawa, Japan
Sendai Kousei Hospital
Sendai, Miyagi, Japan
Nara Medical University Hospital
Kashihara, Nara, Japan
Kishiwada Tokushukai Hospital
Kishiwada, Osaka, Japan
Kasukabe Chuo General Hospital
Kasukabe, Saitama, Japan
Toho University Ohashi Hospital
Meguro, Tokyo, Japan
The Jikei University Hospital
Minato, Tokyo, Japan
Kyushu University Hospital
View full eligibility
Tris trial is registered with FDA with number: NCT01746550. The sponsor of the trial is C. R. Bard and it is looking for 70 volunteers for the current phase.
Official trial 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.
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