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NCT Number: NCT01517997

Infrapopliteal Drug Eluting Angioplasty Versus Stenting

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.

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Key information

Conditions

Arterial Occlusive Disease Arterial Occlusive Diseases Cardiovascular Diseases Vascular Diseases

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Patras University Hospital

Rio, Achaia, 26500, Greece

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

Paclitaxel coated balloon angioplasty.

Procedure

Infrapopliteal angioplasty using a paclitaxel coated balloon.

Other names: DCB

Infrapopliteal Primary Drug Eluting Stenting

Procedure

Infrapopliteal primary stenting using drug-eluting stent(s)

Other names: DES

Primary outcomes

  1. Angiographic Binary Restenosis

    Time frame: 6 months

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

Secondary outcomes

  1. Technical success rate

    Time frame: intra-procedural

    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.

  2. Procedure related complication rates

    Time frame: up to 30 days

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

  3. Target lesion revascularization

    Time frame: 6 months

    Clinically-driven target lesion re-intervention

  4. Limb salvage

    Time frame: 6 months

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

  5. Angiographic Primary Patency

    Time frame: 6 months

    Angiographically proven target lesion patency without any additional revascularization procedure

Sponsors and collaborators

Lead sponsor

University of Patras

Other

Registry information

Official study title

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

Acronym: IDEAS-I

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jan 25, 2012
Registry last updated
Oct 9, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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