The purpose of this study is to confirm that the IN.PACT Admiral is safe and effective for the interventional treatment of new and non-stented restenotic lesions in the superficial femoral artery (SFA) and proximal popliteal artery (PPA) in Chinese patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
143
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter originally developed, approved and commercialized by Invatec Technology Center GmbH is the investigational medical device used in the study. Medtronic Inc. acquired Invatec on April 21, 2010. Medtronic
301 Hospital/Chinese PLA General Hospital
Beijing, China
Anzhen Hospital, Capital Medical University
Beijing, China
Peking University First Hospital
Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR)1 and freedom from restenosis as determined by duplex ultrasound (DUS) Peak Systolic Velocity Ratio (PSVR) ≤ 2.4
Time frame: 12 months
Primary Safety Endpoint
A composite of freedom from device- and procedure-related mortality, freedom from major target limb amputation and freedom from clinicallydriven TLR within 30-day post-index procedure
Time frame: 30 days post-index procedure
Major Adverse Events
MAE is defined as all-cause mortality, clinically-driven Target Vessel Revascularization (TVR), major target limb amputation or thrombosis at the target lesion site, through 12 months
Time frame: 12 months
Death of any cause
Death of any cause at 30 days, 6 and 12 months
Time frame: 30 days, 6 and 12 months
Target Lesion Revascularization
Clinically-driven TLR at 30 days, 6 and 12 months TLR at 6 and 12 months
Time frame: 30 days, 6 and 12 months
Target Vessel Revascularization
Clinically-driven TVR at 30 days, 6 and 12 months TVR at 6 and 12 months
Time frame: 30 days, 6 and 12 months
Major target limb amputation
Major target limb amputation at 30 days, 6 and 12 months
Time frame: 30 days, 6 and 12 months
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Beijing, China
Xuanwu Hospital, Capital Medical University
Beijing, China
West China Hospital
Chengdu, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, China
The First Affiliated Hospital, Dalian Medical University
Dalian, China
The First Affiliated Hospital of Fujian Medical University
Fuzhou, China
The 1stAffiliated Hospital of Sun Yat-sen University
Guangzhou, China
The 2nd Affiliated Hospital of Harbin Medical University
Harbin, China
...and 5 more locations
Thrombosis at the target lesion site
Thrombosis at the target lesion site at 30 days, 6 and 12 months
Time frame: 30 days, 6 and 12 months
Time to first clinically-driven Target Lesion Revascularization
Time to first clinically-driven TLR through 12 months post-index procedure
Time frame: 12 months
Primary sustained clinical improvement
Primary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline without the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 and 12 months
Secondary sustained clinical improvement
Secondary sustained clinical improvement is defined as sustained upward shift of at least 1 category on Rutherford classification as compared to baseline including the need for repeated TLR or surgical revascularization in amputation-free surviving subjects.
Time frame: 6 and 12 months
Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
Duplex-defined binary restenosis (PSVR \> 2.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Time frame: 6 and 12 months
Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
Duplex-defined binary restenosis (PSVR \> 3.4) of the target lesion at 6 and 12 months post-index procedure, or at the time of reintervention prior to any pre-specified time point
Time frame: 6 and 12 months
Walking capacity assessment
Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months
Time frame: 30 days, 6 and 12 months
Walking distance
Walking distance as assessed by 6 Minute Walk Test (6MWT) at 30 days, 6 and 12 months as change from baseline
Time frame: 30 days, 6 and 12 months
Quality of life assessment
Quality of life assessment by EQ5D questionnaire at 30 days, 6 and 12 months as change from baseline
Time frame: 30 days, 6 and 12 months
Device success
Device success is defined as successful delivery, balloon inflation, deflation and retrieval of the intact study device without burst below the rated burst pressure (RBP).
Time frame: Post procedure
Procedural success
Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment.
Time frame: Post procedure
Clinical success
Clinical success is defined as procedural success without procedural complications (death, major target limb amputation, thrombosis of the target lesion, or TVR) prior to discharge.
Time frame: Post procedure
Days of hospitalization due to the target lesion
Days of hospitalization due to the target lesion from procedure through 6 and 12 months
Time frame: 6 and 12 months