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)
|ClinicalTrials.gov Identifier: NCT01746550|
Recruitment Status : Active, not recruiting
First Posted : December 11, 2012
Last Update Posted : March 24, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arterial Occlusive Disease||Device: MD-12-001 Stent||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||December 2012|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
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
- The proportion of subjects who are free of target limb failure at 12-months post study procedure. [ Time Frame: 12-months post study procedure ]
- 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 ]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 ]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) ]
- Rutherford category assessment. [ Time Frame: 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. [ Time Frame: 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.
- Quality of Life (SF-36) Questionnaire [ Time Frame: 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.
- Proportion of Subjects who experience Major Adverse Events. [ Time Frame: 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. [ 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01746550
|Kitakyusyu, Fukuoka, Japan|
|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|
|Principal Investigator:||Masato Nakamura||Toho University Ohashi Hospital|