Peripheral Artery DiseasePESTO-AFCNCT02517827
Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions
A study testing Atherectomy and paclitaxel-coated balloon angioplasty and Open, surgical endarterectomy in people with Peripheral Artery Disease and Artery Stenosis, run by Herz-Zentrums Bad Krozingen at 1 site in Germany.
Trial summary
The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Artery Stenosis
- What is being tested?
- Atherectomy and paclitaxel-coated balloon angioplasty and Open, surgical endarterectomy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 306 participants
- Where
- 1 siteGermany
- Study dates
- 1 Aug 2017to Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be between 21 and 85 years old;
- Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
- Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
- Common femoral artery (CFA) stenosis (including CFA bifurcation) >70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
- At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis >50%).
- Endovascular Procedure: successful target lesion crossing of the guidewire (guidewire located intraluminally);
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- Non-target lesion interventions (TASC A and B) to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion and successful;
- Willing to comply with the specified follow-up evaluation;
- Written informed consent prior to any study procedures.
Who cannot join
- Ipsilateral significant (>50%) stenosis of the iliac arteries.
- Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
- Angiographic evidence of thrombus within target vessel;
- Thrombolysis within 72 hours prior to the index procedure;
- In-Stent restenosis or restenosis of the native common femoral artery.
- Aneurysm in the abdominal aorta or iliac arteries;
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- Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy;
- Recent MI or stroke < 30 days prior to the index procedure;
- Life expectancy less than 24 months;
- Known or suspected active infection at the time of the index procedure;
- Known or suspected allergies or contraindications to aspirin, clopidogrel bisulfate (Plavix) and ticlopidine (Ticlid), heparin, or contrast agent;
- Any significant medical condition which, in the investigator´s opinion, may interfere with the subject´s optimal participation in the study;
- The subject is currently participating in another investigational drug or device study that has not completed the primary endpoint or that clinically interferes with the endpoints of this study.
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
Universitäts-Herzzentrum Freiburg - Bad Krozingen
Bad Krozingen, 79219
Aljoscha Rastan, 004976334024913, aljosch.rastan@universitaets-herzzentrum.de
Thomas Zeller, 004976334022431, thomas.zeller@universitaets-herzzentrum.de
About this study
Official title: Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study
The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended.
The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.
Read the detailed description
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.
- Conditions
- Peripheral Artery Disease, Artery Stenosis
- Being tested
- Atherectomy and paclitaxel-coated balloon angioplasty, Open, surgical endarterectomy
- Keywords
- common femoral artery, drug-coated balloon, surgical endarterectomy
- 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.
Atherectomy and paclitaxel-coated balloon angioplastyDevice
Directional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery
Open, surgical endarterectomyProcedure or surgery
open, surgical endarterectomy of the common femoral artery
| Study group | Role | What they receive |
|---|---|---|
| Endovascular procedure | Active comparator | Common femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel-coated balloon angioplasty. Optional: stentimplantation. Receives: Device: Atherectomy and paclitaxel-coated balloon angioplasty |
| Surgery | Active comparator | Common femoral artery (target lesion) to be treated with open, surgical endarterectomy Receives: Procedure: Open, surgical endarterectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary patency
Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio >2.4.
Measured: 12 month
Secondary outcomes (2)
Primary patency
Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio >2.4.
Measured: 24 month
target lesion revascularisation
Need for target lesion revascularisation after index procedure
Measured: 6, 12, and 24 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2015 (estimated)
- Study start1 Aug 2017
- Primary completionDec 2019 (estimated)
- Study completionDec 2021 (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 Artery 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
- 306 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic
- Responsible party
- Principal investigator, Aljoscha Rastan, Herz-Zentrums Bad Krozingen
- Investigators
- Aljoscha Rastan, MD, Principal investigator, aljoscha.rastan@universitaets-herzzentrum.de
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02517827
- Sponsor's protocol ID
- UHZ_RASA_PESTO_1.0
- Acronym
- PESTO-AFC
- Status last verified
- Aug 2018
- First submitted
- 3 Aug 2015
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Rastan A, Bohme T, Zeller T. Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial. Trials. 2024 Jun 8;25(1):370. doi: 10.1186/s13063-024-08219-1.
PubMed 38851710
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Intervention Versus Surgery in the Treatment of Common Femoral Artery Lesions A Prospective, Multi-centre, Randomised Study
- ClinicalTrials.gov ID
- NCT02517827
- Acronym / sponsor ID
- PESTO-AFC / UHZ_RASA_PESTO_1.0
- Conditions
- Peripheral Artery Disease, Artery Stenosis
- Keywords
- common femoral artery, drug-coated balloon, surgical endarterectomy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 306 participants (estimated)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Collaborators
- Medtronic
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- Dec 2019 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 7 Aug 2015 (estimated)
- 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.
The endovascular therapy prevailed in nearly all regions of peripheral artery disease over open surgery techniques. However, in treatment of the common femoral artery vascular surgery is still the gold standard of therapy. One-year patency rates are between 90% and 95%. Today, only in selected cases an endovascular procedure for common femoral artery diseases is recommended.
The primary objective of this study is to compare the performance of directional atherectomy and drug-coated balloon angioplasty over vascular surgery in common femoral artery lesions in a prospective, multi-center, randomized clinical trial.
Detailed description
Multicenter, prospective, randomized study to be conducted in centers in Europe. A total of 260 subjects will be entered into the study and will be randomized on a 1:1 basis to either directional atherectomy and drug coated balloon angioplasty (optional with stentimplantation), and surgical endarterectomy for treatment in symptomatic (Rutherford-Becker class 2 to 4) common femoral artery disease. All subjects will undergo repeat duplex-ultrasound measurements 6, 12, and 24 months to assess the primary endpoint of Binary Restenosis. Follow-up visits are scheduled 6, 12, and 24 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endovascular procedure | Active comparator | Device: Atherectomy and paclitaxel-coated balloon angioplastyCommon femoral artery (target lesion) to be treated with directional atherectomy and paclitaxel-coated balloon angioplasty. Optional: stentimplantation. |
| Surgery | Active comparator | Procedure: Open, surgical endarterectomyCommon femoral artery (target lesion) to be treated with open, surgical endarterectomy |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject must be between 21 and 85 years old;
- Female of childbearing potential must have a negative pregnancy test within 10 days prior to index procedure and utilize reliable birth control until completion of the 12-month angiographic evaluation;
- Clinical diagnosis of symptomatic peripheral artery disease defined by Rutherford 2, 3, or 4;
- Common femoral artery (CFA) stenosis (including CFA bifurcation) >70% (visual estimate) or occlusion; Additional non-target lesion(s) in remaining non-target vessel(s), except ipsilateral iliac arteries, can be treated at the physician´s discretion;
- At least one vessel outflow (infrapopliteal arteries) to the foot (without stenosis >50%).
Key exclusion criteria (13 listed)
- Ipsilateral significant (>50%) stenosis of the iliac arteries.
- Significant (>50%) stenosis of all infrapopliteal arteries, no patent artery to the foot.
- Angiographic evidence of thrombus within target vessel;
- Thrombolysis within 72 hours prior to the index procedure;
- In-Stent restenosis or restenosis of the native common femoral artery.
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 |
|---|---|---|
| Atherectomy and paclitaxel-coated balloon angioplastyDirectional atherectomy and paclitaxel-coated balloon angioplasty (optional with stentimplantation) of the common femoral artery | Device | Endovascular procedure |
| Open, surgical endarterectomyopen, surgical endarterectomy of the common femoral artery | Procedure or surgery | Surgery |
Primary outcome
Primary patency
Time frame: 12 month
Primary patency of the common femoral artery defined as freedom from target lesion restenosis (luminal narrowing of ≥50%) detected with duplex-ultrasound. The definition of a 50% restenosis is based on the peak systolic velocity ratio >2.4.
2 secondary outcomes
Primary patency
Time frame: 24 month
target lesion revascularisation
Time frame: 6, 12, and 24 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 38851710Rastan A, Bohme T, Zeller T. Percutaneous intervention versus surgery in the treatment of common femoral artery lesions: study protocol for the prospective, multi-center, randomized PESTO-CFA trial. Trials. 2024 Jun 8;25(1):370. doi: 10.1186/s13063-024-08219-1.
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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.
Aljoscha Rastan, MD principal investigator
aljoscha.rastan@universitaets-herzzentrum.de
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atherectomy and paclitaxel-coated balloon angioplasty and Open, surgical endarterectomy in people with Peripheral Artery Disease and Artery Stenosis, run by Herz-Zentrums Bad Krozingen 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 13 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: status not confirmed, as of the sponsor's last update on 3 Aug 2018. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aljoscha Rastan, MD (004976334024913, aljoscha.rastan@universitaets-herzzentrum.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary patency (time frame: 12 month). 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 NCT02517827, 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 3 Aug 2018; AzTrials last refreshed its copy on 8 Nov 2026.