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Arterial Occlusive DiseaseReliableNCT01746550

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

A study testing MD-12-001 Stent in people with Arterial Occlusive Disease, run by C. R. Bard at 12 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
Conditions the study is for
Arterial Occlusive Disease
What is being tested?
MD-12-001 Stent
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
12 sitesJapan
Study dates
Dec 2012to Oct 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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).
Show all 16Show fewer
  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Japan12 sites

  • Kansai Rosai Hospital

    Amagasaki, Hyōgo

  • Kyushu University Hospital

    Fukuoka

  • Shonankamakura General Hospital

    Kamakura, Kanagawa

  • Nara Medical University Hospital

    Kashihara, Nara

  • Kasukabe Chuo General Hospital

    Kasukabe, Saitama

  • Kishiwada Tokushukai Hospital

    Kishiwada, Osaka

  • Kokura Kinen

    Kitakyushu, Fukuoka

  • Toho University Ohashi Hospital

    Meguro City, Tokyo

  • The Jikei University Hospital

    Minato, Tokyo

  • Tokeidai Hospital

    Sapporo, Hokkaido

  • Sendai Kousei Hospital

    Sendai, Miyagi

  • Saiseikai Yokohamashi Tobu Hospital

    Yokohama, Kanagawa

Other trials in Japan

About this study

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.

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.

Being tested
MD-12-001 Stent
Medical subject headings
Arterial Occlusive Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MD-12-001 StentDevice

    Also called Bard Lifestent Vascular Stent

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

Study groups in NCT01746550
Study groupRoleWhat they receive
MD-12-001 Stent ArmExperimentalThis study includes a single arm, the MD-12-001 Stent Arm.
Receives: Device: MD-12-001 Stent

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: 12-months post study procedure

Secondary outcomes (11)

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

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

  2. The proportion of subjects with primary target lesion patency.

    This endpoint will assess whether the study blockage has been unblocked using ultrasound imaging assessments reviewed by an independent core laboratory.

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

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

    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.

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

  4. Proportion of subjects who achieve acute procedural success.

    Measured: Perioperative period (period during study procedure)

  5. Rutherford category assessment.

    The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system.

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

  6. Ankle-brachial index measurements.

    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.

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

  7. Quality of Life (SF-36) Questionnaire

    The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation.

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

  8. Proportion of Subjects who experience Major Adverse Events.

    Major Adverse Events is defined as any death, stroke, myocardial infarction (heart attack) or target limb amputation.

    Measured: 30-days post procedure

  9. Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.

    Measured: through 60-months post study procedure

  10. The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)

    Measured: 12-, 24-, 36-, 48-, and 60-months post study procedure

  11. Proportion of subjects without stent fracture

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Dec 2012 (estimated)
  2. Study startDec 2012
  3. Primary completion11 Oct 2014
  4. Study completionOct 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01746550
Sponsor's protocol ID
MED-12-001
Acronym
Reliable
Status last verified
Apr 2019
First submitted
7 Dec 2012
Last updated
11 Apr 2019
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing MD-12-001 Stent in people with Arterial Occlusive Disease, run by C. R. Bard at 12 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The proportion of subjects who are free of target limb failure at 12-months post study procedure. (time frame: 12-months post study procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01746550.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2019.

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