Peripheral Artery DiseaseADCATNCT01763476
Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions
A study testing paclitaxel-coated balloon angioplasty and atherectomy in people with Peripheral Artery Disease and Occlusion of Artery, run by Herz-Zentrums Bad Krozingen at 1 site in Germany.
Trial summary
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Peripheral Artery Disease, Occlusion of Artery
- What is being tested?
- paclitaxel-coated balloon angioplasty and atherectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2013to Mar 2018
- 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 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject must be between 50 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 critical limb ischemia as defined by Rutherford 3, 4, or 5
- Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm;
- One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement
- The total length of target lesion(s) can be maximum 250 mm
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- In total a maximum of 4 drug-coated balloons may be used to fully cover the target lesion
- Target vessel is 2.0 and 3.5 mm in diameter (visual estimate)
- Target lesion stenosis is >70% diameter stenosis (visual estimate)
- Guidewire must be across the target lesion and located intraluminally within the distal outflow vessel before study randomization
- Interventions in TASC A and B lesions to restore adequate blood flow, in the same index procedure are allowed. This intervention must be prior to the treatment of the study lesion(s) and successful
- Willing to comply with the specified follow-up evaluation
- Written informed consent prior to any study procedures.
Who cannot join
- Significant (>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff;
- Angiographic evidence of thrombus within target vessel
- Thrombolysis within 72 hours prior to the index procedure
- In-Stent restenosis or restenosis of a native artery
- Aneurysm in the femoral artery or popliteal artery
- Concomitant hepatic insufficiency, thrombophlebitis, deep venous thrombus, coagulation disorder or receiving immunosuppressant therapy
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- Recent myocardial infarction or stroke < 30 days prior to the index procedure
- Life expectancy less than 12 months
- Known or suspected active infection at the time of the index procedure, excluding an infection of a lower extremity wound of the target limb
- 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
Universitäts-Herzzentrum Freiburg-Bad Krozingen
Bad Krozingen, 79189
About this study
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%.
The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
Read the detailed description
This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen (Germany). A total of 80 subjects will be entered into the study and will be randomized on a 1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion prior and after intervention will be performed in 15 patients of each group during index procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.
- Conditions
- Peripheral Artery Disease, Occlusion of Artery
- Being tested
- paclitaxel-coated balloon angioplasty, atherectomy
- Keywords
- long infrapopliteal artery lesions, drug-coated balloon angioplasty, atherectomy
- Medical subject headings
- Peripheral Arterial Disease, Arterial Occlusive Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paclitaxel-coated balloon angioplastyProcedure or surgery
plain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion
atherectomyProcedure or surgery
atherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion
| Study group | Role | What they receive |
|---|---|---|
| Paclitaxel-coated balloon angioplasty | Active comparator | Target lesion to be treated with paclitaxel-coated balloon Receives: Procedure: paclitaxel-coated balloon angioplasty |
| Atherectomy + paclitaxel-balloon | Active comparator | Target lesion to be treated with atherectomy (TurboHawk, ev3) and paclitaxel-coated balloon Receives: Procedure: paclitaxel-coated balloon angioplasty; Procedure: atherectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
primary patency
Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4) and angiography (core lab analysis).
Measured: 6 months
Secondary outcomes (1)
target lesion revascularisation (TLR)
Need for target lesion revascularisation from baseline to 6 months after index procedure.
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startJan 2013
- Primary completionMar 2018
- Study completionMar 2018
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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Herz-Zentrums Bad Krozingen
- Sponsor type
- University, hospital or other
- Collaborators
- Medical University of Graz
- Responsible party
- Principal investigator, Aljoscha Rastan, Herz-Zentrums Bad Krozingen
- Investigators
- Franz-Josef Neumann, M.D., Study director, Universitaets-Herzzentrum Freiburg-Bad Krozingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01763476
- Sponsor's protocol ID
- ADCAT(2)
- Acronym
- ADCAT
- Status last verified
- Aug 2018
- First submitted
- 3 Jan 2013
- Last updated
- 3 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Rastan A, Brodmann M, Bohme T, Macharzina R, Noory E, Beschorner U, Flugel PC, Burgelin K, Neumann FJ, Zeller T. Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2021 Jun;14(6):e010280. doi: 10.1161/CIRCINTERVENTIONS.120.010280. Epub 2021 Jun 7.
PubMed 34092093
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
- Atherectomy and Drug-Coated Balloon Angioplasty in Treatment of Long Infrapopliteal Lesions
- ClinicalTrials.gov ID
- NCT01763476
- Acronym / sponsor ID
- ADCAT / ADCAT(2)
- Conditions
- Peripheral Artery Disease, Occlusion of Artery
- Keywords
- long infrapopliteal artery lesions, drug-coated balloon angioplasty, atherectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Herz-Zentrums Bad KrozingenUniversity, hospital or other
- Collaborators
- Medical University of Graz
- Study start
- Jan 2013
- Primary completion
- Mar 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 9 Jan 2013 (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.
There is both a poor life expectancy and a poor prognosis of limb salvage in those patience with stenoses or occlusions of the lower limb (TASC Consensus). To date only a small number of these patients could be helped through medication or surgery. In fact within the first year following diagnosis of a critical limb ischemia 25% of patients lose their leg and 90% have to undergo a percutaneous transluminal angioplasty (PTA) or bypass surgery. Using PTA for treatment of long infrapopliteal artery lesions, stenosis reoccurs in 70% to 80% of cases 3 months after index procedure. Even the use of drug-eluting balloons leads only to 1-year primary patency rates up to 30%.
The primary objective of this study is to compare the performance of atherectomy followed by a drug-coated balloon angioplasty over drug-coated balloon angioplasty alone in long de-novo infrapopliteal lesions in a prospective, single-center, randomized clinical trial.
Detailed description
This is a single-centre, prospective, randomized study to be conducted in Bad Krozingen (Germany). A total of 80 subjects will be entered into the study and will be randomized on a 1:1 basis to either drug-coated balloon angioplasty or atherectomy and drug-coated balloon angioplasty for infrapopliteal use in subjects with long de-novo stenosis (≥6cm) and symptomatic peripheral artery disease (Rutherford 3, 4, or 5). IVUS of the target lesion prior and after intervention will be performed in 15 patients of each group during index procedure. All subjects will undergo a repeat angiography at 3 months to assess the primary endpoint of In-Segment Binary Restenosis. Follow-up visits are scheduled at 3, 6, 12 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel-coated balloon angioplasty | Active comparator | Procedure: paclitaxel-coated balloon angioplastyTarget lesion to be treated with paclitaxel-coated balloon |
| Atherectomy + paclitaxel-balloon | Active comparator | Procedure: paclitaxel-coated balloon angioplasty, Procedure: atherectomyTarget lesion to be treated with atherectomy (TurboHawk, ev3) and paclitaxel-coated balloon |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Subject must be between 50 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 critical limb ischemia as defined by Rutherford 3, 4, or 5
- Single treatment of de-novo lesion(s) in the tibioperoneal trunk, anterior and/or posterior tibial and/or peroneal artery with a lesion length ≥6cm;
- One vessel in 1 limb may be treated in the study. Additional non-target lesion(s) in remaining non-target vessel(s) can be treated at the physician´s discretion by means of balloon dilation or stent placement
Key exclusion criteria (12 listed)
- Significant (>50%) stenoses distal to the target lesion (dorsalis pedis artery, plantar arch) that might require revascularization, or impede runoff;
- Angiographic evidence of thrombus within target vessel
- Thrombolysis within 72 hours prior to the index procedure
- In-Stent restenosis or restenosis of a native artery
- Aneurysm in the femoral artery or popliteal 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 |
|---|---|---|
| paclitaxel-coated balloon angioplastyplain balloon angioplasty followed by paclitaxel-coated balloon angioplasty of the target lesion | Procedure or surgery | Atherectomy + paclitaxel-balloon, Paclitaxel-coated balloon angioplasty |
| atherectomyatherectomy (TurboHawk, ev3) followed by paclitaxel-coated balloon angioplasty of the target lesion | Procedure or surgery | Atherectomy + paclitaxel-balloon |
Primary outcome
primary patency
Time frame: 6 months
Primary patency of the target lesion 6 months after index procedure measured by duplex ultrasound (PVR>2.4) and angiography (core lab analysis).
1 secondary outcome
target lesion revascularisation (TLR)
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2018.
- Derived from this study: PubMed 34092093Rastan A, Brodmann M, Bohme T, Macharzina R, Noory E, Beschorner U, Flugel PC, Burgelin K, Neumann FJ, Zeller T. Atherectomy and Drug-Coated Balloon Angioplasty for the Treatment of Long Infrapopliteal Lesions: A Randomized Controlled Trial. Circ Cardiovasc Interv. 2021 Jun;14(6):e010280. doi: 10.1161/CIRCINTERVENTIONS.120.010280. Epub 2021 Jun 7.
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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.
Franz-Josef Neumann, M.D. study director
Universitaets-Herzzentrum Freiburg-Bad Krozingen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing paclitaxel-coated balloon angioplasty and atherectomy in people with Peripheral Artery Disease and Occlusion of Artery, 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 13 inclusion and 12 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 (time frame: 6 months). 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 NCT01763476, 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.