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Feasibility of Peripheral Angioplasty in Type D TASCII Lesions

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ClinicalTrials.gov Identifier: NCT01297387
Recruitment Status : Completed
First Posted : February 16, 2011
Last Update Posted : February 21, 2011
Sponsor:
Information provided by:

Study Description
Brief Summary:

This observational prospective study will evaluate, according o usual local clinical practice, feasibility of endoluminal revascularization in diabetic patients with type C and D lesions, according to TASC II Criteria.

About 300 patients will be treated with usual revascularization procedure. Each patient will be followed at least 12 months to evaluate clinical outcome and limb salvage interventions.


Condition or disease Intervention/treatment
Diabetes Critical Limb Ischemia Other: PTA BPG procedure,

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Study Design

Study Type : Observational
Actual Enrollment : 344 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: An Observational, Prospective Study Evaluating Feasibility of Peripheral Angioplasty in Diabetic Patients With Critical Limb Ischemia in C and D Obstructions of Transatlantic Inter-Society Consensus (TASC II).
Study Start Date : January 2009
Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Angioplasty
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Revascularization of limb ischemia
Procedure/Surgery
Other: PTA BPG procedure,
Surgery PTA or BPG Procedure, according usual local clinical practice
Other Name: Peripheral angioplasty


Outcome Measures

Eligibility Criteria

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Diabetic patients with critical limb ischemia
Criteria

Inclusion Criteria:

  • Adult diabetic patients type 1 or 2
  • Chronic critical ischemia as defined by TASC 2007 criteria (pain at rest, and/or ulcer or gangrene due to arteriopathy: transcutaneous oximetry < 30 mmHg or pressure on the ankle < 70 mmHg)

Exclusion Criteria:

  • Cancer with adverse prognosis in months, or chemotherapeutic treatment
  • Ongoing or planned pregnancy
  • Lack of consent to participate to the study
Contacts and Locations

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): NCT01297387


Locations
Italy
Diabetic Foot Center IRCCS MultiMedica
Sesto San Giovanni, Milano, Italy, 20099
Sponsors and Collaborators
IRCCS Multimedica
Investigators
Principal Investigator: Ezio Faglia, MD Diabetic Foot Centre IRCCS MultiMedica
More Information

Responsible Party: Ezio faglia MD, Diabetic Foot Center IRCCS MultiMedica, Sesto San Giovanni Milano
ClinicalTrials.gov Identifier: NCT01297387     History of Changes
Other Study ID Numbers: 08/2007_Cardiovascolare
First Posted: February 16, 2011    Key Record Dates
Last Update Posted: February 21, 2011
Last Verified: February 2011

Keywords provided by IRCCS Multimedica:
Diabetic Patients
Critical Limb Ischemia
Revascularization

Additional relevant MeSH terms:
Ischemia
Pathologic Processes