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

NCT ID: NCT01746550

Last Updated: 2019-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-12-31
• Study Completion Date: 2018-10-31

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.

Conditions

Arterial Occlusive Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MD-12-001 Stent Arm

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

Group Type: EXPERIMENTAL

MD-12-001 Stent

Intervention Type: DEVICE

MD-12-001 is a self-expanding nitinol stent

Interventions

MD-12-001 Stent

MD-12-001 is a self-expanding nitinol stent

Intervention Type: DEVICE

Other Intervention Names

Bard Lifestent Vascular Stent

Eligibility Criteria

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

• 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.

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.

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medicon, Inc.

INDUSTRY

Sponsor Role: collaborator

C. R. Bard

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Masato Nakamura

Role: PRINCIPAL_INVESTIGATOR

Toho University Ohashi Hospital

Locations

Kokura Kinen

Kitakyushu, Fukuoka, Japan

Tokeidai Hospital

Sapporo, Hokkaido, Japan

Kansai Rosai Hospital

Amagasaki, Hyōgo, 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 City, Tokyo, Japan

The Jikei University Hospital

Minato, Tokyo, Japan

Kyushu University Hospital

Fukuoka, , Japan

Countries

Japan

Other Identifiers

MED-12-001

Identifier Type: -

Identifier Source: org_study_id