MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery (MDT-2113 SFA)

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

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).

Study Overview

• Status: Completed
• Conditions: Popliteal Artery Stenosis; Popliteal Artery Occlusion; Femoral Artery Occlusion; Femoral Artery Stenosis
• Intervention / Treatment: Device: MDT-2113 Drug-Eluting Balloon; Device: Standard angioplasty balloon

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Hyogo
    • Amagasaki, Hyogo, Japan
      • Kansai Rosai Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 85 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: MDT-2113 Drug-Eluting Balloon; Paclitaxel drug-eluting angioplasty balloon	Device: MDT-2113 Drug-Eluting Balloon; Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
ACTIVE_COMPARATOR: Standard angioplasty balloon; Standard PTA balloon without Paclitaxel drug-elution	Device: Standard angioplasty balloon; Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy: Primary patency	Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS)	12 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Primary safety endpoint	Freedom from device- and procedure-related death through 30 days post-procedure, and freedom from target limb major amputation and clinically-driven target vessel revascularization (TVR)	12 month

Collaborators and Investigators

• Sponsor: Medtronic Endovascular
• Investigators: Principal Investigator: Osamu Iida, MD, Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

Publications and helpful links

General Publications

• 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.
• 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.
• 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. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 1, 2013
• Primary Completion (ACTUAL): April 1, 2018
• Study Completion (ACTUAL): April 1, 2018

Study Registration Dates

• First Submitted: September 17, 2013
• First Submitted That Met QC Criteria: September 19, 2013
• First Posted (ESTIMATE): September 20, 2013

Study Record Updates

• Last Update Posted (ACTUAL): January 31, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Peripheral Artery Disease; Experimental; Drug-Eluting Angioplasty Balloon; Drug Coated Angioplasty Balloon; Percutaneous Transluminal Angioplasty (PTA)
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Arterial Occlusive Diseases; Constriction, Pathologic
• Other Study ID Numbers: 10102118DOC