Back to resultsMDT-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)
Primary Purpose
Femoral Artery Stenosis, Popliteal Artery Stenosis, Femoral Artery Occlusion
Status
Completed
Phase
Not Applicable
Locations
Japan
Study Type
Interventional
Intervention
MDT-2113 Drug-Eluting Balloon
Standard angioplasty balloon
Sponsored by
About this trial
This is an interventional treatment trial for Femoral Artery Stenosis focused on measuring Drug-Eluting Angioplasty Balloon, Drug Coated Angioplasty Balloon, Peripheral Artery Disease, Experimental, 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:
- ≥ 70% and < 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm
- 100% 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
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
Sites / Locations
- Kansai Rosai Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
MDT-2113 Drug-Eluting Balloon
Standard angioplasty balloon
Arm Description
Paclitaxel drug-eluting angioplasty balloon
Standard PTA balloon without Paclitaxel drug-elution
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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)
Full Information
NCT ID
NCT01947478
First Posted
September 17, 2013
Last Updated
January 29, 2019
Sponsor
Medtronic Endovascular
1. Study Identification
Unique Protocol Identification Number
NCT01947478
Brief Title
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
Acronym
MDT-2113 SFA
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
2. Study Status
Record Verification Date
January 2019
Overall Recruitment Status
Completed
Study Start Date
September 2013 (Actual)
Primary Completion Date
April 2018 (Actual)
Study Completion Date
April 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medtronic Endovascular
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
100 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MDT-2113 Drug-Eluting Balloon
Arm Type
Experimental
Arm Description
Paclitaxel drug-eluting angioplasty balloon
Arm Title
Standard angioplasty balloon
Arm Type
Active Comparator
Arm Description
Standard PTA balloon without Paclitaxel drug-elution
Intervention Type
Device
Intervention Name(s)
MDT-2113 Drug-Eluting Balloon
Intervention Description
Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
Intervention Type
Device
Intervention Name(s)
Standard angioplasty balloon
Intervention Description
Subjects will be randomized (2:1) to the MDT-2113 Drug-Eluting Balloon Arm or to the standard non-coated PTA balloon Arm
Primary Outcome Measure Information:
Title
Efficacy: Primary patency
Description
Primary patency is defined as freedom from clinically-driven target lesion revascularization (TLR) and freedom from restenosis as determined by duplex ultrasound (DUS)
Time Frame
12 month
Secondary Outcome Measure Information:
Title
Primary safety endpoint
Description
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)
Time Frame
12 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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:
≥ 70% and < 100% occluded with total lesion length ≥ 40 mm and ≤ 200 mm
100% 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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Iida, MD
Organizational Affiliation
Kansai Rosai Hospital, Amagasaki, Hyogo, Japan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kansai Rosai Hospital
City
Amagasaki
State/Province
Hyogo
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
36137674
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.
Results Reference
derived
PubMed Identifier
32865145
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.
Results Reference
derived
PubMed Identifier
31543165
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.
Results Reference
derived
PubMed Identifier
30690141
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. Erratum In: J Am Coll Cardiol. 2019 Feb 28;:
Results Reference
derived
PubMed Identifier
29264999
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.
Results Reference
derived
Learn more about this trial
MDT-2113 Drug-Eluting Balloon vs. Standard PTA for the Treatment of Atherosclerotic Lesions in the Superficial Femoral Artery and/or Proximal Popliteal Artery
We'll reach out to this number within 24 hrs