Clinical trial NCT01947478: MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
Official title: Randomized Trial of MDT-2113 Drug-Eluting Balloon (DEB) vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Femoral Artery Stenosis
Popliteal Artery Stenosis
Femoral Artery Occlusion
Popliteal Artery Occlusion
Keywords: Drug-Eluting Angioplasty Balloon
Drug Coated Angioplasty Balloon
Peripheral Artery Disease
Experimental
Percutaneous Transluminal Angioplasty (PTA)
Lead sponsor: Medtronic Endovascular
Sponsor class: INDUSTRY
First posted: 2013-09-20
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this trial is to assess the safety and efficacy of MDT-2113 for the interventional treatment of de novo and non-stented restenotic lesions in the superficial femoral artery (SFA) and the proximal popliteal artery (PPA) as compared to treatment with standard percutaneous transluminal angioplasty (PTA).


Eligibility criteria: Inclusion Criteria:

* Age: ≥ 20 years and ≤ 85 years
* Documented ischemia with Rutherford classification 2, 3, or 4
* Able to walk without assistive devices
* Target lesion is in the SFA and/or PPA above the knee
* Target lesion consists of a single de novo or non-stented restenotic lesion (or tandem lesions) or is a combination lesion that meets the following criteria:

  1. ≥ 70% and \< 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm
  2. 100% occluded with total lesion length ≤100 mm
  3. Combination lesions must have total lesion length ≥40 mm and ≤200 mm with an occluded segment that is ≤ 100 mm in length (by visual estimates)
* Reference vessel diameter ≥ 4 mm and ≤7 mm (by visual estimate)
* Angiographic evidence of adequate distal run-off through the foot

Exclusion Criteria:

* Stroke or STEMI within the 3 months prior to enrollment
* Either local or systemic thrombolytic therapy within the 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/antiplatelet therapies or to paclitaxel, or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure
* Chronic renal insufficiency
* Subject is enrolled in another investigational device, drug, or biologic study
* Any major surgical procedure or intervention performed within the 30-day period prior to or post index procedure
* Contralateral SFA/PPA disease requiring treatment in the same setting as index procedure
* Failure to successfully cross the target lesion
* Angiographic evidence of severe calcification
* Target lesion known in advance of enrollment to require treatment with alternative therapy such as stenting, laser, atherectomy, cryoplasty, brachytherapy, re-entry devices, cutting balloons, scoring balloons; use of embolic protection devices is also prohibited

Primary outcomes:
measure: Efficacy: Primary patency
timeFrame: 12 month
Secondary outcomes:
measure: Primary safety endpoint
timeFrame: 12 month
Other outcomes:
Locations:
city: Amagasaki
country: Japan
facility: Kansai Rosai Hospital
state: Hyogo
Study officials:
affiliation: Kansai Rosai Hospital, Amagasaki, Hyogo, Japan
name: Osamu Iida, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Krishnan P, Farhan S, Schneider P, Kamran H, Iida O, Brodmann M, Micari A, Sachar R, Urasawa K, Scheinert D, Ando K, Tarricone A, Doros G, Tepe G, Yokoi H, Laird J, Zeller T. Determinants of Drug-Coated Balloon Failure in Patients Undergoing Femoropopliteal Arterial Intervention. J Am Coll Cardiol. 2022 Sep 27;80(13):1241-1250. doi: 10.1016/j.jacc.2022.06.043.
citation: Soga Y, Iida O, Urasawa K, Saito S, Jaff MR, Wang H, Ookubo H, Yokoi H. Three-Year Results of the IN.PACT SFA Japan Trial Comparing Drug-Coated Balloons With Percutaneous Transluminal Angioplasty. J Endovasc Ther. 2020 Dec;27(6):946-955. doi: 10.1177/1526602820948240. Epub 2020 Aug 31.
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: 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.
citation: Iida O, Soga Y, Urasawa K, Saito S, Jaff MR, Wang H, Ookubo H, Yokoi H; MDT-2113 SFA Japan Investigators. Drug-Coated Balloon vs Standard Percutaneous Transluminal Angioplasty for the Treatment of Atherosclerotic Lesions in the Superficial Femoral and Proximal Popliteal Arteries: One-Year Results of the MDT-2113 SFA Japan Randomized Trial. J Endovasc Ther. 2018 Feb;25(1):109-117. doi: 10.1177/1526602817745565. Epub 2017 Dec 21.