NCT01558505

Brief Summary

Drug-eluting balloon showed positive results in terms of restenosis reduction in peripheral intervention (PTA). The aim of the study is to investigate in a randomized fashion the efficacy and safety of Paclitaxel-eluting balloon (PEB) (In.Pact Amphirion, Invatec, Brescia, Italy) versus non drug-eluting balloon (NEB) (Amphirion deep, Invatec, Brescia, Italy) in diabetic patients with Critical Limb Ischemia (CLI) undergoing PTA of below-the-knee (BTK) vessels.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
142

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

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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 17, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 20, 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 17, 2012

Last Update Submit

January 26, 2013

Conditions

Critical Limb Ischemia

Keywords

critical limb ischemiadrug-eluting balloonrestenosis

Outcome Measures

Primary Outcomes (1)

  • angiographic binary restenosis

    incidence of binary restenosis

    12 months

Secondary Outcomes (3)

  • major amputation

    24 motnhs

  • target lesion revascularization

    24 months

  • vessel reocclusion

    24 months

Study Arms (2)

standard PTA

ACTIVE COMPARATOR

conventional balloon angioplasty

Device: POBA

Drug-eluting balloon angioplasty

EXPERIMENTAL

paclitaxel-eluting balloon angioplasty

Device: PEB

Interventions

PEBDEVICE

paclitaxel-eluting balloon angioplasty

Drug-eluting balloon angioplasty
POBADEVICE

conventional balloon angioplasty

standard PTA

Eligibility Criteria

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

You may qualify if:

  • age\>18 years
  • angiographic stenosis\>50% or occlusion of one below-knee vessel

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
  • need for amputation

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, Porto I, Angioli P, Grotti S, Ricci L, Ducci K, Falsini G, Ventoruzzo G, Turini F, Bellandi G, Bolognese L. Drug-eluting balloon in peripheral intervention for below the knee angioplasty evaluation (DEBATE-BTK): a randomized trial in diabetic patients with critical limb ischemia. Circulation. 2013 Aug 6;128(6):615-21. doi: 10.1161/CIRCULATIONAHA.113.001811.

    PMID: 23797811DERIVED

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial DiseaseAtherosclerosisArteriosclerosisArterial Occlusive DiseasesVascular DiseasesCardiovascular DiseasesPeripheral Vascular DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsIschemia

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

Study Record Dates

First Submitted

March 17, 2012

First Posted

March 20, 2012

Study Start

November 1, 2010

Primary Completion

September 1, 2012

Last Updated

January 29, 2013

Record last verified: 2013-01

Locations

IT(1)