Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IN.PACT Admiral | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter | Device | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | 30 days post-index procedure |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 12 months |
| Death of any cause |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Zhong Chen, Prof | Vascular Department Anzhen Hospital, Capital Medical University | Principal Investigator |
| Wei Guo, Prof | Vascular Department 301 Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 301 Hospital/Chinese PLA General Hospital | Beijing | China | ||||
| Anzhen Hospital, Capital Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31543165 | Derived | Shishehbor MH, Schneider PA, Zeller T, Razavi MK, Laird JR, Wang H, Tieche C, Parikh SA, Iida O, Jaff MR. Total IN.PACT drug-coated balloon initiative reporting pooled imaging and propensity-matched cohorts. J Vasc Surg. 2019 Oct;70(4):1177-1191.e9. doi: 10.1016/j.jvs.2019.02.030. | |
| 31204595 | Derived | Chen Z, Guo W, Jiang W, Wang F, Fu W, Zou Y, Deckers S, Li P, Popma JJ, Jaff MR. IN.PACT SFA Clinical Study Using the IN.PACT Admiral Drug-Coated Balloon in a Chinese Patient Population. J Endovasc Ther. 2019 Aug;26(4):471-478. doi: 10.1177/1526602819852084. Epub 2019 Jun 17. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
Death of any cause at 30 days, 6 and 12 months
| 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 | 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 | 30 days, 6 and 12 months |
| Major target limb amputation | Major target limb amputation at 30 days, 6 and 12 months | 30 days, 6 and 12 months |
| Thrombosis at the target lesion site | Thrombosis at the target lesion site at 30 days, 6 and 12 months | 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 | 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. | 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. | 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 | 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 | 6 and 12 months |
| Walking capacity assessment | Walking capacity assessment by Walking Impairment Questionnaire (WIQ) at 30 days, 6 and 12 months | 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 | 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 | 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). | Post procedure |
| Procedural success | Procedural success is defined as residual stenosis of ≤ 50% (non-stented subjects) or ≤ 30% (stented subjects) by core lab assessment. | 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. | 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 | 6 and 12 months |
| Beijing |
| China |
| Peking University First Hospital | Beijing | China |
| Xuanwu Hospital, Capital Medical University | Beijing | China |
| West China Hospital | Chengdu | 610041 | China |
| The First Affiliated Hospital of Chongqing Medical University | Chongqing | 400016 | 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 |
| The first affiliated Hospital of Harbin Medical University | Harbin | China |
| Nanjing Drum Tower Hospital | Nanjing | China |
| Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine | Shanghai | 200011 | China |
| Zhongshan Hospital, Fudan University | Shanghai | China |
| Shengjing Hospital of China Medical University | Shenyang | China |
| 30690141 | Derived | Schneider PA, Laird JR, Doros G, Gao Q, Ansel G, Brodmann M, Micari A, Shishehbor MH, Tepe G, Zeller T. Mortality Not Correlated With Paclitaxel Exposure: An Independent Patient-Level Meta-Analysis of a Drug-Coated Balloon. J Am Coll Cardiol. 2019 May 28;73(20):2550-2563. doi: 10.1016/j.jacc.2019.01.013. Epub 2019 Jan 25. |
| ID | Term |
|---|---|
| D050197 | Atherosclerosis |
| ID | Term |
|---|---|
| D001161 | Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided