Feasibility of Peripheral Angioplasty in Type D TASCII Lesions

This study has been completed.
Sponsor:
Information provided by:
IRCCS Multimedica
ClinicalTrials.gov Identifier:
NCT01297387
First received: February 15, 2011
Last updated: February 18, 2011
Last verified: February 2011
  Purpose

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 Intervention
Diabetes
Critical Limb Ischemia
Other: PTA BPG procedure,

Study Type: Observational
Study Design: 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).

Resource links provided by NLM:


Further study details as provided by IRCCS Multimedica:

Enrollment: 344
Study Start Date: January 2009
Study Completion Date: December 2009
Groups/Cohorts Assigned Interventions
Revascularization of limb ischemia
Procedure/Surgery
Other: PTA BPG procedure,
Surgery PTA or BPG Procedure, according usual local clinical practice
Other Name: Peripheral angioplasty

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: February 15, 2011
Last Updated: February 18, 2011
Health Authority: Italy: Ethics Committee

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

Additional relevant MeSH terms:
Ischemia
Pathologic Processes

ClinicalTrials.gov processed this record on July 23, 2014