Clinical trial NCT02118532: The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Official title: The IN.PACT SFA Clinical Study for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery Using the IN.PACT Admiral™ Drug-Eluting Balloon in a Chinese Patient Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Atherosclerosis
Keywords: Atherosclerosis
Superficial Femoral Artery
Proximal Popliteal Artery
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2014-04-21
Enrollment: 143
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
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 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.


Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years and ≤ 85 years.
* Subject with documented diagnosis of peripheral arterial disease (PAD) classified as Rutherford class 2-3-4 in the superficial femoral artery (SFA) and/or proximal popliteal artery (PPA) above the knee, located in the arterial segment starting at least 1 cm beyond the Common femoral artery (CFA) bifurcation between the superficial and profunda femoris arteries (proximal anatomical landmark to the distal P1 segment of the popliteal artery at the level of the proximal edge of the patella (distal anatomical landmark).
* Target lesion consists of a single de novo or non-stented restenotic lesion (or a tandem lesion) or is a combination lesion
* Reference vessel diameter ≥ 4 mm and ≤ 7 mm by visual estimate.
* Subject able to walk without assistive devices (e.g. walker, cane).
* If subject has ipsilateral/contralateral iliac disease that requires treatment during the index procedure
* Angiographic evidence of adequate distal run-off to the foot (at least one native calf vessel \[posterior tibial, anterior tibial, or peroneal arteries\] is patent, defined as \< 50% diameter stenosis).
* Female subjects of childbearing potential must have a negative pregnancy test ≤ 7 days before index procedure and willing to use a reliable method of birth control for the duration of the study or must have documented adequate birth control.
* Signed and dated Patient Informed Consent (PIC) form.
* Understands and accepts the duration of the study and is able and willing to comply with all requirements, including follow-up visits and evaluations.
* Life expectancy, in the Investigator's opinion, of at least 12 months.

Exclusion Criteria:

* In the investigator's opinion subject is unlikely to comply with the followup schedule.
* Stroke or STEMI within the 3 months prior to index procedure.
* Either local or systemic thrombolytic therapy within 48 hours prior to the index procedure.
* Inability to tolerate oral anticoagulation therapy (blood thinners such as warfarin) while on concomitant dual antiplatelet therapy (DAPT).
* Known allergies or sensitivities to heparin, aspirin (ASA), other anticoagulant/anti-platelet therapies, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
* Breastfeeding woman.
* Chronic renal insufficiency with serum creatinine \> 2.5 mg/dL within 14 days prior to index procedure.
* WBC \< 3.0 (3,000 cells/mm3) within 14 days prior to index procedure.
* PLT count \< 80,000 cells/mm3 or \> 700,000 cells/mm3 within 14 days prior to index procedure.
* Known or suspected active systemic infection evidenced by WBC \> 14.0 (14000/mm3) within 14 days prior to index procedure.
* Diagnosed with bleeding diatheses or hypercoagulable state.
* Subject is enrolled in another investigational device, drug or biologic study or subject was previously enrolled to the IN.PACT SFA China trial.
* Any major (e.g., cardiac. peripheral, abdominal) surgical procedure or intervention performed within 30 days prior to the index procedure.
* Any major (e.g., cardiac. peripheral, abdominal) elective procedure or intervention within 30 days post index procedure.
* Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure.
* Presence of additional lesions in the target vessel that require treatment during index procedure but do not meet the definitions of tandem lesions.
* Target lesion is an in-stent or post-DEB restenosis or has been previously treated with bypass surgery.
* Failure to successfully cross the target lesion with a guide wire
* Lesion within or adjacent to an aneurysm.
* Acute or sub-acute thrombus in the target vessel.
* Angiographic evidence of severe calcification
* Target lesion known in advance of enrollment to require treatment with alternative therapy such as drug-eluting stent (DES), drug-eluting balloon (DEB), laser, atherectomy, cryoplasty, re-entry devices, cutting/scoring balloon, brachytherapy. Use of embolic protection devices is also prohibited.
* Pre-dilation resulted in a major ( ≥ Grade D) flow-limiting dissection (observed on 2 orthogonal views) or residual stenosis \> 70% and translesional peak gradient \> 10mm Hg.

Primary outcomes:
measure: Primary effectiveness endpoint: Primary patency within 12 months post-index procedure
timeFrame: 12 months
measure: Primary Safety Endpoint
timeFrame: 30 days post-index procedure
Secondary outcomes:
measure: Major Adverse Events
timeFrame: 12 months
measure: Death of any cause
timeFrame: 30 days, 6 and 12 months
measure: Target Lesion Revascularization
timeFrame: 30 days, 6 and 12 months
measure: Target Vessel Revascularization
timeFrame: 30 days, 6 and 12 months
measure: Major target limb amputation
timeFrame: 30 days, 6 and 12 months
measure: Thrombosis at the target lesion site
timeFrame: 30 days, 6 and 12 months
measure: Time to first clinically-driven Target Lesion Revascularization
timeFrame: 12 months
measure: Primary sustained clinical improvement
timeFrame: 6 and 12 months
measure: Secondary sustained clinical improvement
timeFrame: 6 and 12 months
measure: Duplex-defined binary restenosis (PSVR > 2.4) of the target lesion
timeFrame: 6 and 12 months
measure: Duplex-defined binary restenosis (PSVR > 3.4) of the target lesion
timeFrame: 6 and 12 months
measure: Walking capacity assessment
timeFrame: 30 days, 6 and 12 months
measure: Walking distance
timeFrame: 30 days, 6 and 12 months
measure: Quality of life assessment
timeFrame: 30 days, 6 and 12 months
measure: Device success
timeFrame: Post procedure
measure: Procedural success
timeFrame: Post procedure
measure: Clinical success
timeFrame: Post procedure
measure: Days of hospitalization due to the target lesion
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Beijing
country: China
facility: 301 Hospital/Chinese PLA General Hospital
city: Beijing
country: China
facility: Anzhen Hospital, Capital Medical University
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Xuanwu Hospital, Capital Medical University
city: Chengdu
country: China
facility: West China Hospital
city: Chongqing
country: China
facility: The First Affiliated Hospital of Chongqing Medical University
city: Dalian
country: China
facility: The First Affiliated Hospital, Dalian Medical University
city: Fuzhou
country: China
facility: The First Affiliated Hospital of Fujian Medical University
city: Guangzhou
country: China
facility: The 1stAffiliated Hospital of Sun Yat-sen University
city: Harbin
country: China
facility: The 2nd Affiliated Hospital of Harbin Medical University
city: Harbin
country: China
facility: The first affiliated Hospital of Harbin Medical University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Shanghai 9th People Hospital Affiliated Shanghai Jiao Tong University School of Medecine
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
city: Shenyang
country: China
facility: Shengjing Hospital of China Medical University
Study officials:
affiliation: Vascular Department Anzhen Hospital, Capital Medical University
name: Zhong Chen, Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Vascular Department 301 Hospital
name: Wei Guo, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.