AzTrials
AzTrials

Arterial Occlusive DiseasePhase 2/3IDEAS-INCT01517997

Infrapopliteal Drug Eluting Angioplasty Versus Stenting

A Phase 2/3 study testing Paclitaxel coated balloon angioplasty. and Infrapopliteal Primary Drug Eluting Stenting in people with Arterial Occlusive Disease, run by University of Patras at 1 site in Greece.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in… Read more about this study

Who is it for?
Ages 18 to 90 years
Conditions the study is for
Arterial Occlusive Disease
What is being tested?
Paclitaxel coated balloon angioplasty. and Infrapopliteal Primary Drug Eluting Stenting
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
1 siteGreece
Study dates
Aug 2011to Sep 2013
Phase
Phase 2/3
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 to 90 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Angiographically documented infrapopliteal disease.
  • Rutherford category of peripheral arterial disease between class 3 to 6
  • Lesion length between 70 to 220 mm
  • Lesions situated in the proximal, mid and mid to distal segments of the tibial vessels.

Who cannot join

  • Lesion length < 70 mm or > 220 mm.
  • Lesions situated in the distal third of the tibial vessels

Trial locations and contacts

1 site in 1 country.

Greece1 site

  • Patras University Hospital

    Rio, Achaia, 26500

Other trials in Greece

About this study

Official title: Infrapopliteal Drug Eluting Angioplasty Versus Stenting for the Treatment of Long-segment Arterial Disease: The IDEAS-I Randomized Controlled Trial.

In total 50 patients diagnosed with long-segment infrapopliteal arterial disease will be randomized in two groups. The patients randomized in the Drug coated balloons (DCB) study arm will undergo a percutaneous transluminal angioplasty (PTA) with the use of a paclitaxel-coated balloon, while the patients randomized in the drug-eluting stent (DES) study arm will undergo primary stenting using drug-eluting stent(s). The study's primary endpoints will be the 6-month angiographic binary restenosis rate. Secondary endpoints will include the immediate technical success,6-month primary patency, target lesion revascularization and limb salvage and complication rates.

Read the detailed description

Patients programmed to undergo PTA due to angiographically-proven infrapopliteal arterial disease in our department will be randomized in the above mentioned study arms. The studies primary endpoint will be assessed with the use of intra-arterial digital subtracted angiography and subsequent Quantitative Vascular Analysis (QVA) analysis.Clinical follow-up is set at 1, 3 and 6 months. Patients' baseline demographics and procedural details will be recorded and analyzed.

Being tested
Paclitaxel coated balloon angioplasty., Infrapopliteal Primary Drug Eluting Stenting
Keywords
Drug coated balloons, Drug eluting stents
Medical subject headings
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 angioplasty.Procedure or surgery

    Also called DCB

    Infrapopliteal angioplasty using a paclitaxel coated balloon.

  • Infrapopliteal Primary Drug Eluting StentingProcedure or surgery

    Also called DES

    Infrapopliteal primary stenting using drug-eluting stent(s)

Study groups in NCT01517997
Study groupRoleWhat they receive
Drug Coated Balloon (DCB) ArmExperimentalPatients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.
Receives: Procedure: Paclitaxel coated balloon angioplasty.
Drug Eluting Stents (DES) ArmActive comparatorPatients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.
Receives: Procedure: Infrapopliteal Primary Drug Eluting Stenting

What is being measured

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

  1. Angiographic Binary Restenosis

    Angiographic binary restenosis of the target lesion defined by quantitative vessel analysis at 6 months follow-up

    Measured: 6 months

Secondary outcomes (5)

  1. Technical success rate

    Successful balloon angioplasty without stent use due to flow limiting dissection or/and <30% remaining target lesion stenosis in the DCB arm and successful balloon angioplasty without flow limiting dissection or/and <30% remaining target lesion stenosis in the DES arm.

    Measured: intra-procedural

  2. Procedure related complication rates

    procedure related major and minor complication rates identified during the procedure or within 30 days after the completion of the procedure.

    Measured: up to 30 days

  3. Target lesion revascularization

    Clinically-driven target lesion re-intervention

    Measured: 6 months

  4. Limb salvage

    Major amputation-free interval of the treated limb at 6 months follow-up

    Measured: 6 months

  5. Angiographic Primary Patency

    Angiographically proven target lesion patency without any additional revascularization procedure

    Measured: 6 months

Timeline

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

  1. First posted25 Jan 2012 (estimated)
  2. Study startAug 2011
  3. Primary completionSep 2013
  4. Study completionSep 2013

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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
50 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01517997
Sponsor's protocol ID
20884/25-8-11
Acronym
IDEAS-I
Status last verified
Oct 2013
First submitted
2 Dec 2011
Last updated
9 Oct 2013
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

  • Siablis D, Kitrou PM, Spiliopoulos S, Katsanos K, Karnabatidis D. Paclitaxel-coated balloon angioplasty versus drug-eluting stenting for the treatment of infrapopliteal long-segment arterial occlusive disease: the IDEAS randomized controlled trial. JACC Cardiovasc Interv. 2014 Sep;7(9):1048-56. doi: 10.1016/j.jcin.2014.04.015.

    PubMed 25234679

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Paclitaxel coated balloon angioplasty. and Infrapopliteal Primary Drug Eluting Stenting in people with Arterial Occlusive Disease, run by University of Patras at 1 site in Greece.

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 4 inclusion and 2 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 9 Oct 2013. 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 Greece. 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 combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

Angiographic Binary Restenosis (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 NCT01517997, 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 9 Oct 2013.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in