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Peripheral Vascular DiseasePhase 4ISAR-PEBISNCT01083394

Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

A Phase 4 study testing PTA, PTA with PEB and Percutaneous Transluminal Angioplasty (PTA) in people with Peripheral Vascular Disease, run by Deutsches Herzzentrum Muenchen at 2 sites in Germany.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Peripheral Vascular Disease
What is being tested?
PTA, PTA with PEB and Percutaneous Transluminal Angioplasty (PTA)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
2 sitesGermany
Study dates
Mar 2010to Dec 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% in-stent restenosis of the AFS, (Rutherford stage 2-6)
  • Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Who cannot join

  • Acute ischemia and/or acute thrombosis of the SFA
  • Untreated ipsilateral iliac artery stenosis >70%
  • Not at least one vessel run-off
  • Popliteal involvement with stenosis >70%
  • Severe renal insufficiency (GFR <30 ml/min/m2)
  • Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
Show all 9Show fewer
  • Pregnancy (present, suspected or planned) or positive pregnancy test.
  • Previous enrollment in this trial.
  • Patient's inability to fully cooperate with the study protocol.

Trial locations and contacts

2 sites in 1 country.

Julinda Mehilli, MD contact

+49 89 12 18 ext. 4582

mehilli@dhm.mhn.de

Ilka V. Ott, MD contact

+49 89 41 40 ext. 4360

ott@dhm.de

Germany2 sites, 2 recruiting

  • 1. Medizinische Klinik, Klinikum rechts der Isar

    München

    Ilka V. Ott, MD, +49 89 4140 ext. 4360, ott@dhm.mhn.de

    Ilka V. Ott, MD

    Recruiting

  • Deutsches Herzzentrum

    München

    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

Other trials in Germany

About this study

Official title: Randomized Trial of Paclitaxel Eluting Balloon or Conventional Balloon for Treatment of In-Stent Restenosis of the Superficial Femoral Artery in Patients With Symptomatic Peripheral Artery Disease (ISAR-PEBIS)

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

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. Restenosis after PTA occurs in 40-60% within one year. A novel 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 these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

Being tested
PTA, PTA with PEB, Percutaneous Transluminal Angioplasty (PTA)
Keywords
PTA, paclitaxel, restenosis
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.

  • PTADevice

    Also called PACIFIC XTREME, Invatec

    PTA using a conventional balloon

  • PTA with PEBDevice

    Also called IN.PACT PACIFIC, Invatec

    PTA using a paclitaxel eluting balloon

  • Percutaneous Transluminal Angioplasty (PTA)Procedure or surgery

    Also called PACIFIC XTREME or IN.PACT PACIFIC balloons

    Percutaneous transluminal angioplasty with conventional balloon or paclitaxel-eluting balloon

Study groups in NCT01083394
Study groupRoleWhat they receive
conventional PTAActive comparatorIn stent restenosis is treated with PTA using a conventional balloon.
Receives: Device: PTA; Procedure: Percutaneous Transluminal Angioplasty (PTA)
PTA with PEBExperimentalIn stent restenosis is treated with PTA using a paclitaxel eluting balloon.
Receives: Device: PTA with PEB; Procedure: Percutaneous Transluminal Angioplasty (PTA)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage diameter stenosis

    Measured: 6 months

Secondary outcomes (5)

  1. All-cause mortality

    Measured: 6 and 24 months

  2. Major adverse peripheral events (MAPE) defined as acute thrombosis of SFA or ipsilateral amputation or revascularization (PTA or bypass surgery)

    Measured: 6 Months

  3. Time to onset of any of MAPE

    Measured: 3-24 months

  4. Binary restenosis rate

    Measured: 6 months

  5. Percentage diameter stenosis in duplex ultrasound

    Measured: 6 and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Mar 2010 (estimated)
  2. Study startMar 2010
  3. Primary completionDec 2014 (estimated)
  4. Study completionDec 2015 (estimated)

Resources

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
70 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01083394
Sponsor's protocol ID
GE IDE No. B00210
Acronym
ISAR-PEBIS
Status last verified
Apr 2010
First submitted
26 Feb 2010
Last updated
10 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 42573020

  • Ott I, Cassese S, Groha P, Steppich B, Voll F, Hadamitzky M, Ibrahim T, Kufner S, Dewitz K, Wittmann T, Kasel AM, Laugwitz KL, Schunkert H, Kastrati A, Fusaro M. ISAR-PEBIS (Paclitaxel-Eluting Balloon Versus Conventional Balloon Angioplasty for In-Stent Restenosis of Superficial Femoral Artery): A Randomized Trial. J Am Heart Assoc. 2017 Jul 25;6(7):e006321. doi: 10.1161/JAHA.117.006321.

    PubMed 28743787

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing PTA, PTA with PEB and Percutaneous Transluminal Angioplasty (PTA) in people with Peripheral Vascular Disease, 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 9 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 10 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 Julinda Mehilli, MD (+49 89 12 18 ext. 4582, mehilli@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 NCT01083394, 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 10 Mar 2014.

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