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

NCT01746550 | Completed

• 1 other identifier: MED-12-001
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 12

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

Outcome Measures

Primary Outcomes (1)

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

  12-months post study procedure

Secondary Outcomes (11)

• The proportion of subjects who are free of target limb failure.

  30-days, 6-, 24-, and 36-months post study procedure

• The proportion of subjects with primary target lesion patency.

  30-days, 6-, 12-, 24-, and 36-months post study procedure

• The proportion of subjects with secondary target vessel/lesion patency.

  30-days, 6-, 12-, 24-, and 36-months post study procedure

• Proportion of subjects who achieve acute procedural success.

  Perioperative period (period during study procedure)

• Rutherford category assessment.

  Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure

Study Arms (1)

MD-12-001 Stent Arm

EXPERIMENTAL

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

Device: MD-12-001 Stent

Interventions

MD-12-001 Stent DEVICE

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

Also known as: Bard Lifestent Vascular Stent

MD-12-001 Stent Arm

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• C. R. Bard: lead
• Medicon, Inc.: collaborator

Study Sites (12)

Kokura Kinen

Kitakyushu, Fukuoka, Japan

Location

Tokeidai Hospital

Sapporo, Hokkaido, Japan

Location

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Shonankamakura General Hospital

Kamakura, Kanagawa, Japan

Location

Saiseikai Yokohamashi Tobu Hospital

Yokohama, Kanagawa, Japan

Location

Sendai Kousei Hospital

Sendai, Miyagi, Japan

Location

Nara Medical University Hospital

Kashihara, Nara, Japan

Location

Kishiwada Tokushukai Hospital

Kishiwada, Osaka, Japan

Location

Kasukabe Chuo General Hospital

Kasukabe, Saitama, Japan

Location

Toho University Ohashi Hospital

Meguro City, Tokyo, Japan

Location

The Jikei University Hospital

Minato, Tokyo, Japan

Location

Kyushu University Hospital

Fukuoka, Japan

Location

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Masato Nakamura

  Toho University Ohashi Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2012
• First Posted: December 11, 2012
• Study Start: December 1, 2012
• Primary Completion: October 11, 2014
• Study Completion: October 1, 2018
• Last Updated: April 11, 2019

Record last verified: 2019-04

Locations

JP (12)