NCT01517997

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Aug 2011

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2011

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 2, 2011

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 25, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 9, 2013

Status Verified

October 1, 2013

Enrollment Period

2.1 years

First QC Date

December 2, 2011

Last Update Submit

October 8, 2013

Conditions

Arterial Occlusive Disease

Keywords

Drug coated balloonsDrug eluting stents

Outcome Measures

Primary Outcomes (1)

  • Angiographic Binary Restenosis

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

    6 months

Secondary Outcomes (5)

  • Technical success rate

    intra-procedural

  • Procedure related complication rates

    up to 30 days

  • Target lesion revascularization

    6 months

  • Limb salvage

    6 months

  • Angiographic Primary Patency

    6 months

Study Arms (2)

Drug Coated Balloon (DCB) Arm

EXPERIMENTAL

Patients included in this arm will undergo PTA with the use of a paclitaxel coated balloon.

Procedure: Paclitaxel coated balloon angioplasty.

Drug Eluting Stents (DES) Arm

ACTIVE COMPARATOR

Patients in this arm will undergo primary infrapopliteal stenting of the target lesion using a drug-eluting stent.

Procedure: Infrapopliteal Primary Drug Eluting Stenting

Interventions

Paclitaxel coated balloon angioplasty.PROCEDURE

Infrapopliteal angioplasty using a paclitaxel coated balloon.

Also known as: DCB
Drug Coated Balloon (DCB) Arm
Infrapopliteal Primary Drug Eluting StentingPROCEDURE

Infrapopliteal primary stenting using drug-eluting stent(s)

Also known as: DES
Drug Eluting Stents (DES) Arm

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Patras University Hospital

Rio, Achaia, 26500, Greece

Location

Related Publications (1)

  • 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.

    PMID: 25234679DERIVED

MeSH Terms

Conditions

Arterial Occlusive Diseases

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Dimitrios Siablis, MD,PhD

    University Hospital of Patras

    STUDY CHAIR

  • Dimitrios Karnabatidis, MD, PhD

    University Hospital of Patras

    STUDY DIRECTOR

  • Konstantinos Katsanos, MD, PhD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

  • Stavros Spiliopoulos, MD, PhD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

  • Athanasios Diamantopoulos, MD

    Patras Univesrity Hospital

    PRINCIPAL INVESTIGATOR

  • Panagiotis Kitrou, MD

    University Hospital of Patras

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of RAdiology

Study Record Dates

First Submitted

December 2, 2011

First Posted

January 25, 2012

Study Start

August 1, 2011

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

October 9, 2013

Record last verified: 2013-10

Locations

GR(1)