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)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Medicon, Inc.
Information provided by (Responsible Party):
C. R. Bard
ClinicalTrials.gov Identifier:
NCT01746550
First received: December 7, 2012
Last updated: January 16, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Arterial Occlusive Disease
Device: MD-12-001 Stent

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official 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.

Further study details as provided by C. R. Bard:

Primary Outcome Measures:
  • The proportion of subjects who are free of target limb failure at 12-months post study procedure. [ Time Frame: 12-months post study procedure ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The proportion of subjects who are free of target limb failure. [ Time Frame: 30-days, 6-, 24-, and 36-months post study procedure ] [ Designated as safety issue: No ]
  • The proportion of subjects with primary target lesion patency. [ Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure ] [ Designated as safety issue: No ]
    This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.

  • The proportion of subjects with secondary target vessel/lesion patency. [ Time Frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure ] [ Designated as safety issue: No ]
    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.

  • Proportion of subjects who achieve acute procedural success. [ Time Frame: Perioperative period (period during study procedure) ] [ Designated as safety issue: No ]
  • Rutherford category assessment. [ Time Frame: Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure ] [ Designated as safety issue: No ]
    The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.

  • Ankle-brachial index measurements. [ Time Frame: Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure ] [ Designated as safety issue: No ]
    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.

  • Quality of Life (SF-36) Questionnaire [ Time Frame: Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure ] [ Designated as safety issue: No ]
    The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.

  • Proportion of Subjects who experience Major Adverse Events. [ Time Frame: 30-days post procedure ] [ Designated as safety issue: Yes ]
    Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.

  • Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event. [ Time Frame: through 60-months post study procedure ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: Yes ]
  • Proportion of subjects without stent fracture [ Time Frame: 30-days, 6-, 12-, 24, and 36-months post study procedure ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 70
Study Start Date: December 2012
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Bard Lifestent Vascular Stent

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01746550

Locations
Japan
Kokura Kinen
Kitakyusyu, Fukuoka, Japan
Tokeidai Hospital
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
Fukuoka, Japan
Sponsors and Collaborators
C. R. Bard
Medicon, Inc.
Investigators
Principal Investigator: Masato Nakamura Toho University Ohashi Hospital
  More Information

No publications provided

Responsible Party: C. R. Bard
ClinicalTrials.gov Identifier: NCT01746550     History of Changes
Other Study ID Numbers: MED-12-001
Study First Received: December 7, 2012
Last Updated: January 16, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Additional relevant MeSH terms:
Arterial Occlusive Diseases
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 23, 2014