Peripheral Vascular DiseasesPhase 4ISAR-STATHNCT00986752
Efficacy Study of Stenting, Paclitaxel Eluting Balloon or Atherectomy to Treat Peripheral Artery Disease
A Phase 4 study testing Stenting (Smart Stent), Stenting after PEB (Smart Stent, Invatec) and Atherectomy (SilverHawk device) in people with Peripheral Vascular Diseases, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.
Trial summary
The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Diseases
- What is being tested?
- Stenting (Smart Stent), Stenting after PEB (Smart Stent, Invatec) and Atherectomy (SilverHawk device)
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 2 sitesGermany
- Study dates
- Jul 2009to Mar 2015
- Phase
- Phase 4
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
- Written informed consent
Who cannot join
- Acute ischemia and/or acute thrombosis of the SFA
- Untreated ipsilateral iliac artery stenosis >70%
- Previous stenting of the SFA
- Popliteal stenosis >70%
- Severe renal insufficiency
Trial locations and contacts
2 sites in 1 country.
Germany2 sites, 2 recruiting
- Recruiting
Deutsches Herzzentrum
München, 80636
Massimiliano Fusaro, MD, +49 89-1218 ext. 4566, fusaro@dhm.mhn.de
Tarek Ibrahim, MD, +49 89-1218 ext. 4016, ibrahim@dhm.mhn.de
- Recruiting
I. Medizinische Klinik, Klinikum rechts der Isar
München, 81675
Ilka Ott, MD, +49-89-4140 ext. 4360, ott@dhm.mhn.de
Ilka Ott, MD
About this study
Official title: Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease
The purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.
Read the detailed description
The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern.
Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization.
There is no randomized comparison of this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.
- Conditions
- Peripheral Vascular Diseases
- Being tested
- Stenting (Smart Stent), Stenting after PEB (Smart Stent, Invatec), Atherectomy (SilverHawk device)
- Keywords
- stent, atherectomy, paclitaxel-eluting balloon
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stenting (Smart Stent)Device
Also called Smart Stent, Cordis, Johnson & Johnson
Nitinol stent
Stenting after PEB (Smart Stent, Invatec)Device
Also called Invatec, Smart Stent, Cordis, Johnson & Johnson
Stenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB).
Atherectomy (SilverHawk device)Procedure or surgery
Also called SilverHawk device (EV3 Inc)
Atherectomy
| Study group | Role | What they receive |
|---|---|---|
| Stenting | Active comparator | Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon. Receives: Device: Stenting (Smart Stent) |
| Stenting after PEB | Experimental | Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon. Receives: Device: Stenting (Smart Stent); Device: Stenting after PEB (Smart Stent, Invatec) |
| Atherectomy | Experimental | The third randomization arm is Atherectomy. Receives: Procedure: Atherectomy (SilverHawk device) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage diameter stenosis
Measured: 6 months
Secondary outcomes (6)
All-cause mortality
Measured: 6 and 24 months
Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)
Measured: 6 months
Time to onset of any of MAPE.
Measured: 3-24 months
Binary restenosis rate
Measured: 6 months
Percentage diameter stenosis in duplex ultrasound
Measured: 6 and 24 months
Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)
Measured: 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2009 (estimated)
- Study startJul 2009
- Primary completionDec 2014 (estimated)
- Study completionMar 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseasesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Deutsches Herzzentrum Muenchen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Adnan Kastrati, MD, Study chair, Deutsches Herzzentrum MünchenIlka Ott, MD, Principal investigator, Klinikum rechts der Isar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00986752
- Sponsor's protocol ID
- GE IDE No. B00101
- Acronym
- ISAR-STATH
- Status last verified
- Jan 2010
- First submitted
- 29 Sep 2009
- Last updated
- 7 Mar 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Hiendlmayer R, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH). Circulation. 2017 Jun 6;135(23):2218-2226. doi: 10.1161/CIRCULATIONAHA.116.025329. Epub 2017 Apr 19.
PubMed 28424222
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Stenting After Dilation With or Without Paclitaxel Eluting Balloon or Atherectomy in Patients With Symptomatic Peripheral Artery Disease
- ClinicalTrials.gov ID
- NCT00986752
- Acronym / sponsor ID
- ISAR-STATH / GE IDE No. B00101
- Conditions
- Peripheral Vascular Diseases
- Keywords
- stent, atherectomy, paclitaxel-eluting balloon
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Deutsches Herzzentrum MuenchenUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Mar 2015 (estimated)
- First posted
- 30 Sep 2009 (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 purpose of the study is to evaluate the efficacy of stenting after dilation with or without paclitaxel-eluting balloon or atherectomy in patients with symptomatic peripheral artery disease.
Detailed description
The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Despite the initial technical success rate of more than 95% the late clinical failure remains an important concern.
Restenosis after PTA occurs in 40-60% within one year. Percutaneous removal of the obstructive material through atherectomy may reduce restenosis rate. So far, data in support of excisional atherectomy derive from registries. Another attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization.
There is no randomized comparison of this three different interventional strategies. Thus the aim of this study is to evaluate the efficacy of these strategies in terms or reduction of diameter stenosis at follow-up angiogram.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Stenting | Active comparator | Device: Stenting (Smart Stent)Due to randomization one nitinol stent will be implanted after dilation with a conventional balloon. |
| Stenting after PEB | Experimental | Device: Stenting (Smart Stent), Device: Stenting after PEB (Smart Stent, Invatec)Due to randomization one nitinol stent will be implanted after dilation with a Paclitaxel eluting balloon. |
| Atherectomy | Experimental | Procedure: Atherectomy (SilverHawk device)The third randomization arm is Atherectomy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Symptomatic ≥ 70% stenosis of the SFA (Rutherford stage 2-6)
- Written informed consent
Key exclusion criteria (5 listed)
- Acute ischemia and/or acute thrombosis of the SFA
- Untreated ipsilateral iliac artery stenosis >70%
- Previous stenting of the SFA
- Popliteal stenosis >70%
- Severe renal insufficiency
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 |
|---|---|---|
| Stenting (Smart Stent)Also: Smart Stent, Cordis, Johnson & JohnsonNitinol stent | Device | Stenting, Stenting after PEB |
| Stenting after PEB (Smart Stent, Invatec)Also: Invatec, Smart Stent, Cordis, Johnson & JohnsonStenting (nitinol stent) after dilation with Paclitaxel-eluting balloon (PEB). | Device | Stenting after PEB |
| Atherectomy (SilverHawk device)Also: SilverHawk device (EV3 Inc)Atherectomy | Procedure or surgery | Atherectomy |
Primary outcome
Percentage diameter stenosis
Time frame: 6 months
6 secondary outcomes
All-cause mortality
Time frame: 6 and 24 months
Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)
Time frame: 6 months
Time to onset of any of MAPE.
Time frame: 3-24 months
Binary restenosis rate
Time frame: 6 months
Percentage diameter stenosis in duplex ultrasound
Time frame: 6 and 24 months
Change from baseline in functional status and health related quality of life (Walking Impairment Questionaire)
Time frame: 3 and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2014.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 28424222Ott I, Cassese S, Groha P, Steppich B, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Hiendlmayer R, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. Randomized Comparison of Paclitaxel-Eluting Balloon and Stenting Versus Plain Balloon Plus Stenting Versus Directional Atherectomy for Femoral Artery Disease (ISAR-STATH). Circulation. 2017 Jun 6;135(23):2218-2226. doi: 10.1161/CIRCULATIONAHA.116.025329. Epub 2017 Apr 19.
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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.
Adnan Kastrati, MD study chair
Deutsches Herzzentrum München
Ilka Ott, MD principal investigator
Klinikum rechts der Isar
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Stenting (Smart Stent), Stenting after PEB (Smart Stent, Invatec) and Atherectomy (SilverHawk device) in people with Peripheral Vascular Diseases, run by Deutsches Herzzentrum Muenchen at 2 sites 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 2 inclusion and 5 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 7 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Klaus Tiroch, MD (+49-89-1218 ext. 1538, tiroch@dhm.mhn.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage diameter stenosis (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 NCT00986752, which also lists 2 linked publications.
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 7 Mar 2014.