Arterial Occlusive Disease
Conditions
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.
Interventions
DEVICEMD-12-001 Stent
MD-12-001 is a self-expanding nitinol stent
Sponsors
Medicon, Inc.
C. R. Bard
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects who are free of target limb failure at 12-months post study procedure. | 12-months post study procedure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The proportion of subjects with primary target lesion patency. | 30-days, 6-, 12-, 24-, and 36-months post study procedure | 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. | 30-days, 6-, 12-, 24-, and 36-months post study procedure | 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. | Perioperative period (period during study procedure) | — |
| Rutherford category assessment. | Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure | The assessment of peripheral artery disease severity will be performed using the Rutherford Classification system. |
| Ankle-brachial index measurements. | Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure | 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. |
| The proportion of subjects who are free of target limb failure. | 30-days, 6-, 24-, and 36-months post study procedure | — |
| Proportion of Subjects who experience Major Adverse Events. | 30-days post procedure | 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. | through 60-months post study procedure | — |
| The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow) | 12-, 24-, 36-, 48-, and 60-months post study procedure | — |
| Proportion of subjects without stent fracture | 30-days, 6-, 12-, 24, and 36-months post study procedure | — |
| Quality of Life (SF-36) Questionnaire | Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure | The SF-36 Quality of Life Questionnaire (QOL) will be used to evaluate QOL changes during study participation. |
Countries
Japan
Outcome results
None listed