Peripheral Arterial DiseaseNCT03776799
BEST SFA Pilot Study - Best Endovascular STrategy for Complex Lesions of the Superficial Femoral Artery
A study testing Stent-avoiding and Stent-based in people with Peripheral Arterial Disease, run by University of Leipzig at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Stent-avoiding and Stent-based
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2019to Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Stent-avoiding, Stent-based
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stent-avoidingDevice
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-basedDevice
Stenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries
| Study group | Role | What they receive |
|---|---|---|
| Stent-avoiding approach | Other | using clinically proven drug coated balloons Receives: Device: Stent-avoiding |
| Stent-based approach | Other | using drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion. Receives: Device: Stent-based |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 Year
Secondary outcomes (4)
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)
Measured: 2 Year
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
Measured: 2 Year
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
Measured: 2 Year
Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
Measured: 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2018
- Study start1 Jan 2019
- Primary completion24 Aug 2022
- Study completionJul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dierk Scheinert, University of Leipzig
- Investigators
- Dierk Scheinert, Prof. Dr., Principal investigator, University Clinic Leipzig
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03776799
- Sponsor's protocol ID
- CIP_18/001
- Status last verified
- Apr 2026
- First submitted
- 5 Dec 2018
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 38749594
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03776799
- Acronym / sponsor ID
- CIP_18/001
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 24 Aug 2022 (actual)
- Study completion
- Jul 2026 (estimated)
- First posted
- 17 Dec 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stent-avoiding approach | Other | Device: Stent-avoidingusing clinically proven drug coated balloons |
| Stent-based approach | Other | Device: Stent-basedusing drug eluting nitinol stents. Interwoven nitinol stents in heavily calcified lesions at the operator's discretion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (20 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stent-avoidingPercutaneous 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 | Device | Stent-avoiding approach |
| Stent-basedStenting, in which a stent is advanced and implanted in the obstructed artery, has become the standard endovascular treatment for peripheral arteries | Device | Stent-based approach |
Primary outcome
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
4 secondary outcomes
Walking capacity - Walking capacity assessed by Walking impairment questionnaire score at 6, 12 and 24
Time frame: 2 Year
Ankle-brachial index - Clinical improvment assessed by Ankle-brachial index at 6, 12 and 24 month
Time frame: 2 Year
Rutherford category - Clinical improvment assessed by Rutherford category at 6, 12 and 24 month
Time frame: 2 Year
Freedom from device and procedure-related death, all-cause death, target limb major amputation and clinically-driven target lesion revascularization
Time frame: 5 Years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Derived from this study: PubMed 38749594Wittig 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dierk Scheinert, Prof. Dr. principal investigator
University Clinic Leipzig
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stent-avoiding and Stent-based in people with Peripheral Arterial Disease, run by University of Leipzig at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03776799, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2026; AzTrials last refreshed its copy on 30 Oct 2026.