Back to resultsBEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Primary Purpose
Peripheral Arterial Disease
Status
Active
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Stent-avoiding
Stent-based
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral Arterial Disease
Eligibility Criteria
Inclusion Criteria:
- Subject age ≥ 18
- 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.
- Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
- Rutherford Becker Classification 2-4
- Both treatment options seem feasible at the operator's discretion
- Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
- Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
- 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
- A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
- Failure to successfully cross the target lesion
- Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
- Femoropopliteal lesions classified as TASC II Typ A (single stenosis >=10cm and single occlusion >=5cm)
- Presence of fresh thrombus in the lesion.
- Presence of aneurysm in the target vessel/s
- Presence of a stent in the target lesion
- Prior vascular surgery of the target lesion.
- Stroke or heart attack within 3 months prior to enrollment
- Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
- SFA or PPA disease in the opposite leg that requires treatment at the index procedure
- Enrolled in another investigational drug, device or biologic study that interferes with the study
- Life expectancy of less than one year
- 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
- Rutherford classification of 0, 1, 5 or 6.
- Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
- Platelet count <100,000 mm3 or >600,000 mm3
- Receiving dialysis or immunosuppressant therapy
- Pregnant or lactating females.
- History of major amputation in the same limb as the target lesion
- Chronic kidney disease (serum creatinine > 3 mg/dL)
Sites / Locations
- University Clinic Leipzig
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Stent-avoiding approach
Stent-based approach
Arm Description
using clinically proven drug coated balloons
using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.
Outcomes
Primary Outcome Measures
Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound
Secondary Outcome Measures
Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24
The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)
Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month
The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease
Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month
This classification system consists of four grades and seven categories (categories 0-6):
Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene
Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
Full Information
NCT ID
NCT03776799
First Posted
December 5, 2018
Last Updated
November 21, 2022
Sponsor
University of Leipzig
1. Study Identification
Unique Protocol Identification Number
NCT03776799
Brief Title
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
Official Title
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery Comparing a Stent-avoiding (Study Arm) Versus Stent-preferred (Control Arm) Approach Within a Prospective, Randomized, Multi-center Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
August 24, 2022 (Actual)
Study Completion Date
July 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Leipzig
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Prospective, multi-center 1:1 randomized trial to compare efficacy and safety of a stent-avoiding (using drug coated balloons) versus a stent-preferred (using drug eluting or interwoven stents) approach for treatment of complex femoropopliteal lesions TASC II (TransAtlantic Inter-Society Consensus for the Management of Peripheral Arterial Disease) Type B-D (stenosis >10cm, occlusions >5cm).
Detailed Description
Prospective, multi-center 1:1 randomized Study.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Stent-avoiding approach
Arm Type
Other
Arm Description
using clinically proven drug coated balloons
Arm Title
Stent-based approach
Arm Type
Other
Arm Description
using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion.
Intervention Type
Device
Intervention Name(s)
Stent-avoiding
Intervention Description
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
Intervention Type
Device
Intervention Name(s)
Stent-based
Intervention Description
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
Primary Outcome Measure Information:
Title
Primary patency - Absence of clinically-driven target lesion revascularization (CD-TLR) and/or restenosis defined as a peak systolic velocity ratio (PSVR) > 2.4 assessed by ultrasound
Time Frame
1 Year
Secondary Outcome Measure Information:
Title
Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24
Description
The graded score is multiplied by a pre-specified weight for each distance, speed, or number of stair flights. The products are summed and divided by the maximum possible score to obtain a percent score, ranging from 0 (representing the inability to perform any of the tasks) to 100 (representing no difficult with any of the tasks)
Time Frame
2 Year
Title
Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month
Description
The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressure in the arm. An ABI between and including 0.9 and 1.2 considered normal (free from significant PAD), while a lesser than 0.9 indicates arterial disease
Time Frame
2 Year
Title
Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month
Description
This classification system consists of four grades and seven categories (categories 0-6):
Grade 0, Category 0: asymptomatic Grade I, Category 1: mild claudication Grade I, Category 2: moderate claudication Grade I, Category 3: severe claudication Grade II, Category 4: rest pain Grade III, Category 5: minor tissue loss; ischemic ulceration not exceeding ulcer of the digits of the foot Grade IV, Category 6: major tissue loss; severe ischemic ulcers or frank gangrene
Time Frame
2 Year
Title
Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
Time Frame
5 Years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject age ≥ 18
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.
Subject has a de novo or restenotic lesion with ≥ 70% stenosis documented angiographically and no prior stent in the target lesion.
Rutherford Becker Classification 2-4
Both treatment options seem feasible at the operator's discretion
Femoropopliteal lesions classified as TASC II Type B-D with a maximum lesion length ≤ 30cm not involving the infrageniculate popliteal artery are eligible.
Reference vessel diameter (RVD) ≥ 4 mm and ≤ 6.5 mm by visual estimation.
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
A guidewire has successfully traversed the target treatment segment.
Exclusion Criteria:
Failure to successfully cross the target lesion
Angiographic evidence of severe calcification that makes a stent-avoiding approach not feasible at the operator's discretion.
Femoropopliteal lesions classified as TASC II Typ A (single stenosis >=10cm and single occlusion >=5cm)
Presence of fresh thrombus in the lesion.
Presence of aneurysm in the target vessel/s
Presence of a stent in the target lesion
Prior vascular surgery of the target lesion.
Stroke or heart attack within 3 months prior to enrollment
Any planned surgical procedure or intervention performed within 30 days prior to or post index procedure
SFA or PPA disease in the opposite leg that requires treatment at the index procedure
Enrolled in another investigational drug, device or biologic study that interferes with the study
Life expectancy of less than one year
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
Rutherford classification of 0, 1, 5 or 6.
Significant gastrointestinal bleeding or any coagulopathy that would contraindicate the use of anti-platelet therapy.
Platelet count <100,000 mm3 or >600,000 mm3
Receiving dialysis or immunosuppressant therapy
Pregnant or lactating females.
History of major amputation in the same limb as the target lesion
Chronic kidney disease (serum creatinine > 3 mg/dL)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dierk Scheinert, Prof. Dr.
Organizational Affiliation
University Clinic Leipzig
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Clinic Leipzig
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
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