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Evaluating the Effectiveness of Paclitaxel-eluting Balloons for Below-the-knee Angioplasty in Patients With Critical Limb Ischemia

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ClinicalTrials.gov Identifier: NCT01938872
Recruitment Status : Unknown
Verified September 2013 by Leonardo Bolognese, MD, Ospedale San Donato.
Recruitment status was:  Recruiting
First Posted : September 10, 2013
Last Update Posted : September 10, 2013
Sponsor:
Information provided by (Responsible Party):
Leonardo Bolognese, MD, Ospedale San Donato

Brief Summary:
to evaluate the the effectiveness of paclitaxel-eluting balloon for below-the-knee angioplasty in terms of restenosis at 12 months

Condition or disease Intervention/treatment
Critical Limb Ischemia Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 12 Months
Study Start Date : September 2013
Estimated Primary Completion Date : September 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
Drug Information available for: Paclitaxel

Group/Cohort Intervention/treatment
PEB angioplasty
paclitaxel eluting balloon angioplasty in below-the-knee lesions
Procedure: paclitaxel eluting balloon angioplasty in below-the-knee lesions
Other Name: FREEWAY™ (Eurocor GmbH)




Primary Outcome Measures :
  1. angiographic binary restenosis [ Time Frame: 12 months ]
    incidence of binary restenosis



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients undergoing below-the-knee angioplasty with paclitaxel eluting balloon for critical limb ischemia
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01938872


Locations
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Italy
Cardiovascular Department, Ospedale S.Donato Recruiting
Arezzo, AR, Italy, 52100
Contact: Francesco Liistro, MD       francescoliistro@hotmail.com   
Principal Investigator: Leonardo Bolognese, MD, FESC         
Sub-Investigator: Giovanni Falsini, MD         
Sub-Investigator: Paolo Angioli, MD         
Sub-Investigator: Kenneth Ducci, MD         
Principal Investigator: Francesco Liistro, MD         
Sub-Investigator: Simone Grotti, MD         
Sub-Investigator: Italo Porto, MD         
Sponsors and Collaborators
Ospedale San Donato

Additional Information:

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Responsible Party: Leonardo Bolognese, MD, Director, Ospedale San Donato
ClinicalTrials.gov Identifier: NCT01938872     History of Changes
Other Study ID Numbers: Arezzo010
First Posted: September 10, 2013    Key Record Dates
Last Update Posted: September 10, 2013
Last Verified: September 2013

Keywords provided by Leonardo Bolognese, MD, Ospedale San Donato:
critical limb ischemia
drug-eluting balloon
restenosis

Additional relevant MeSH terms:
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Ischemia
Pathologic Processes
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action