Clinical trial NCT01746550: 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
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Arterial Occlusive Disease
Lead sponsor: C. R. Bard
Sponsor class: INDUSTRY
Collaborators: name: Medicon, Inc.
First posted: 2012-12-11
Enrollment: 70
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: The proportion of subjects who are free of target limb failure at 12-months post study procedure.
timeFrame: 12-months post study procedure
Secondary outcomes:
measure: The proportion of subjects who are free of target limb failure.
timeFrame: 30-days, 6-, 24-, and 36-months post study procedure
measure: The proportion of subjects with primary target lesion patency.
timeFrame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
measure: The proportion of subjects with secondary target vessel/lesion patency.
timeFrame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
measure: Proportion of subjects who achieve acute procedural success.
timeFrame: Perioperative period (period during study procedure)
measure: Rutherford category assessment.
timeFrame: Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
measure: Ankle-brachial index measurements.
timeFrame: Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
measure: Quality of Life (SF-36) Questionnaire
timeFrame: Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
measure: Proportion of Subjects who experience Major Adverse Events.
timeFrame: 30-days post procedure
measure: Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
timeFrame: through 60-months post study procedure
measure: The proportion of subjects who undergo target vessel/lesion revascularization (restoration of blood flow)
timeFrame: 12-, 24-, 36-, 48-, and 60-months post study procedure
measure: Proportion of subjects without stent fracture
timeFrame: 30-days, 6-, 12-, 24, and 36-months post study procedure
Other outcomes:
Locations:
city: Kitakyushu
country: Japan
facility: Kokura Kinen
state: Fukuoka
city: Sapporo
country: Japan
facility: Tokeidai Hospital
state: Hokkaido
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
city: Kamakura
country: Japan
facility: Shonankamakura General Hospital
state: Kanagawa
city: Yokohama
country: Japan
facility: Saiseikai Yokohamashi Tobu Hospital
state: Kanagawa
city: Sendai
country: Japan
facility: Sendai Kousei Hospital
state: Miyagi
city: Kashihara
country: Japan
facility: Nara Medical University Hospital
state: Nara
city: Kishiwada
country: Japan
facility: Kishiwada Tokushukai Hospital
state: Osaka
city: Kasukabe
country: Japan
facility: Kasukabe Chuo General Hospital
state: Saitama
city: Meguro
country: Japan
facility: Toho University Ohashi Hospital
state: Tokyo
city: Minato
country: Japan
facility: The Jikei University Hospital
state: Tokyo
city: Fukuoka
country: Japan
facility: Kyushu University Hospital
Study officials:
affiliation: Toho University Ohashi Hospital
name: Masato Nakamura
role: PRINCIPAL_INVESTIGATOR
References: