BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
NCT ID: NCT03776799
Last Updated: 2024-12-09
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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ACTIVE_NOT_RECRUITING
NA
120 participants
INTERVENTIONAL
2019-01-01
2026-07-31
Brief Summary
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Detailed Description
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Patients will be stratified according to a stent-avoiding (study arm) or stent-preferred (control arm)
In total 120 patient will be enrolled in this study, each strata will include 60 patients.
All enrolled patients will be followed up for 24 month to asses the incidence of restenosis by duplex ultrasound and major adverse events.
Follow-up visits occur at 6, 12 and 24 month intervals as well as telephone visit after 1,36, 48 and 60 month.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Stent-avoiding approach
using clinically proven drug coated balloons
Stent-avoiding
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Stent-based approach
using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.
Stent-based
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
Interventions
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Stent-avoiding
Percutaneous transluminal angioplasty (PTA), in which a balloon is advanced and inflated in the obstructed artery for several seconds to minutes, has become the standard endovascular treatment for peripheral arteries
Stent-based
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
Eligibility Criteria
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Inclusion Criteria
2. Subject has been informed of the nature of the study, agrees to participate, and has signed a Medical Ethics Committee approved consent form Subject understands the duration of the study, agrees to attend follow-up visits, and agrees to complete the required testing.
3. Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
4. Rutherford Becker Classification 2-4
5. Both treatment options seem feasible at the operator's discretion
6. Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
7. Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
8. Patency of at least one (1) infrapopliteal artery to the ankle (\< 50% diameter stenosis) in continuity with the native femoropopliteal artery. The inflow artery(ies) cannot be treated using a drug eluting stent or drug coated balloon
9. A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria
2. Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
3. Femoropopliteal lesions classified as TASC II Typ A (single stenosis \>=10cm and single occlusion \>=5cm)
4. Presence of fresh thrombus in the lesion.
5. Presence of aneurysm in the target vessel/s
6. Presence of a stent in the target lesion
7. Prior vascular surgery of the target lesion.
8. Stroke or heart attack within 3 months prior to enrollment
9. Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
10. SFA or PPA disease in the opposite leg that requires treatment at the index procedure
11. Enrolled in another investigational drug, device or biologic study that interferes with the study
12. Life expectancy of less than one year
13. Known allergies or sensitivity to heparin, aspirin, other anticoagulant/ antiplatelet therapies, paclitaxel or contrast media that cannot be adequately pre-treated prior to index procedure
14. Rutherford classification of 0, 1, 5 or 6.
15. Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
16. Platelet count \<100,000 mm3 or \>600,000 mm3
17. Receiving dialysis or immunosuppressant therapy
18. Pregnant or lactating females.
19. History of major amputation in the same limb as the target lesion
20. Chronic kidney disease (serum creatinine \> 3 mg/dL)
18 Years
ALL
No
Sponsors
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University of Leipzig
OTHER
Responsible Party
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Dierk Scheinert
Clinic director
Principal Investigators
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Dierk Scheinert, Prof. Dr.
Role: PRINCIPAL_INVESTIGATOR
University Clinic Leipzig
Locations
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University Clinic Leipzig
Leipzig, Saxony, Germany
Countries
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References
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Wittig T, Schmidt A, Fuss T, Thieme M, Maiwald L, Dusing S, Konert M, Fischer A, Scheinert D, Steiner S. Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv. 2024 May 13;17(9):1134-1144. doi: 10.1016/j.jcin.2024.03.015.
Other Identifiers
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CIP_18/001
Identifier Type: -
Identifier Source: org_study_id