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

NCT01947478 | Completed DMC

• 1 other identifier: 10102118DOC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Primary safety endpoint

  12 month

Study Arms (2)

MDT-2113 Drug-Eluting Balloon

EXPERIMENTAL

Paclitaxel drug-eluting angioplasty balloon

Device: MDT-2113 Drug-Eluting Balloon

Standard angioplasty balloon

ACTIVE COMPARATOR

Standard PTA balloon without Paclitaxel drug-elution

Device: Standard angioplasty balloon

Interventions

MDT-2113 Drug-Eluting Balloon DEVICE

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

MDT-2113 Drug-Eluting Balloon

Standard angioplasty balloon DEVICE

Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm

Standard angioplasty balloon

Eligibility Criteria

• Age: 20 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• ≥ 70% and \< 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm
• % occluded with total lesion length ≤100 mm
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Endovascular: lead

Study Sites (1)

Kansai Rosai Hospital

Amagasaki, Hyōgo, Japan

Location

Related Publications (5)

• 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.

  PMID: 36137674 DERIVED

• 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.

  PMID: 32865145 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.

  PMID: 31543165 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.

  PMID: 30690141 DERIVED

• 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.

  PMID: 29264999 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• Osamu Iida, MD

  Kansai Rosai Hospital, Amagasaki, Hyogo, Japan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 17, 2013
• First Posted: September 20, 2013
• Study Start: September 1, 2013
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 31, 2019

Record last verified: 2019-01

Locations

JP (1)