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
NCT ID: NCT02118532
Last Updated: 2016-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
143 participants
INTERVENTIONAL
2014-03-31
2016-09-30
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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IN.PACT Admiral
IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
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
Interventions
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IN.PACT Admiral Paclitaxel-Eluting Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter
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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
85 Years
ALL
No
Sponsors
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Medtronic Endovascular
INDUSTRY
Responsible Party
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Principal Investigators
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Zhong Chen, Prof
Role: PRINCIPAL_INVESTIGATOR
Vascular Department Anzhen Hospital, Capital Medical University
Wei Guo, Prof
Role: PRINCIPAL_INVESTIGATOR
Vascular Department 301 Hospital
Locations
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301 Hospital/Chinese PLA General Hospital
Beijing, , China
Anzhen Hospital, Capital Medical University
Beijing, , China
Peking University First Hospital
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
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, , China
Zhongshan Hospital, Fudan University
Shanghai, , China
Shengjing Hospital of China Medical University
Shenyang, , China
Countries
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References
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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.
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.
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.
Other Identifiers
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IN.PACT SFA China
Identifier Type: -
Identifier Source: org_study_id