NCT01556542

Brief Summary

The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for phase_4

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

November 1, 2010

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Last Updated

January 29, 2013

Status Verified

January 1, 2013

Enrollment Period

1.8 years

First QC Date

March 13, 2012

Last Update Submit

January 26, 2013

Conditions

Peripheral Arterial Disease

Keywords

peripheral arterial diseasedrug-eluting balloonrestenosis

Outcome Measures

Primary Outcomes (1)

  • angiographic binary restenosis

    incidence of binary restenosis

    12 months

Secondary Outcomes (3)

  • major amputation

    24 months

  • target lesion revascularization

    24 months

  • vessel reocclusion

    24 months

Study Arms (2)

standard PTA

ACTIVE COMPARATOR

nitinol stent implantation

Device: nitinol stent implantation

DEB

EXPERIMENTAL

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

Interventions

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantationDEVICE

paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation

DEB
nitinol stent implantationDEVICE

nitinol stent implantation

standard PTA

Eligibility Criteria

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

You may qualify if:

  • age\>18 years
  • intermittent claudication(Fontane III or IV)
  • angiographic stenosis\>50% or occlusion of superficial femoral-popliteal artery\>40mm
  • at least one below-knee vessel to the ankle

You may not qualify if:

  • allergy to Paclitaxel
  • contraindication for combined antiplatelet treatment
  • life expectancy \<1 year
  • hypersensitivity or contraindication to one of the study drugs
  • lack of consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular Department, Ospedale S.Donato

Arezzo, AR, 52100, Italy

Location

Related Publications (1)

  • Liistro F, Grotti S, Porto I, Angioli P, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for the superficial femoral artery: the DEBATE-SFA randomized trial (drug eluting balloon in peripheral intervention for the superficial femoral artery). JACC Cardiovasc Interv. 2013 Dec;6(12):1295-302. doi: 10.1016/j.jcin.2013.07.010. Epub 2013 Nov 13.

    PMID: 24239203DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

AtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular Diseases

Study Officials

  • Francesco Liistro, MD

    Cardiovascular Department, San Donato Hospital, Arezzo, Italy

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director of Cardiovascular Department

Study Record Dates

First Submitted

March 13, 2012

First Posted

March 16, 2012

Study Start

November 1, 2010

Primary Completion

September 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

IT(1)