Overview

This trial is active, not recruiting.

Condition arterial occlusive disease
Treatment md-12-001 stent
Sponsor C. R. Bard
Collaborator Medicon, Inc.
Start date December 2012
End date December 2018
Trial size 70 participants
Trial identifier NCT01746550, MED-12-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
This study includes a single arm, the MD-12-001 Stent Arm.
md-12-001 stent Bard Lifestent Vascular Stent
MD-12-001 is a self-expanding nitinol stent

Primary Outcomes

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

Secondary Outcomes

Measure
The proportion of subjects who are free of target limb failure.
time frame: 30-days, 6-, 24-, and 36-months post study procedure
The proportion of subjects with primary target lesion patency.
time frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
The proportion of subjects with secondary target vessel/lesion patency.
time frame: 30-days, 6-, 12-, 24-, and 36-months post study procedure
Proportion of subjects who achieve acute procedural success.
time frame: Perioperative period (period during study procedure)
Rutherford category assessment.
time frame: Baseline, 30-days. 3-. 6-. 12-. 24-. 36-. 48- and 60-months post study procedure
Ankle-brachial index measurements.
time frame: Baseline, 30-days, 3-, 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Quality of Life (SF-36) Questionnaire
time frame: Baseline, 30-days, 3- , 6-, 12-, 24-, 36-, 48-, and 60-months post study procedure
Proportion of Subjects who experience Major Adverse Events.
time frame: 30-days post procedure
Proportions of Subjects who experience 1) any adverse event and 2) any serious adverse event.
time frame: through 60-months post study procedure
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
Proportion of subjects without stent fracture
time frame: 30-days, 6-, 12-, 24, and 36-months post study procedure

Eligibility Criteria

Male or female participants at least 20 years old.

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.

Additional Information

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.
Principal investigator Masato Nakamura
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by C. R. Bard.