Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes

Shanghai 10th People's Hospital1 site in 1 country300 target enrollmentAugust 1, 2016

ConditionsPeripheral Vascular Disease in Diabetes

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Peripheral Vascular Disease in Diabetes
Sponsor: Shanghai 10th People's Hospital
Enrollment: 300
Locations: 1
Primary Endpoint: Coincidence rate of "5 points test of Tongji university"
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.

Registry

clinicaltrials.gov

Start Date

August 1, 2016

End Date

July 31, 2018

Last Updated

7 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Shanghai 10th People's Hospital

Responsible Party

Principal Investigator

Maoquan Li

Chief Physician

Shanghai 10th People's Hospital

Eligibility Criteria

Inclusion Criteria

•1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-
•3.Target lesions with a diameter reduction of at least 50% on angiography, and without past history of any intervention.
•4.Target vessel with 2.0--10.0mm in diameter and having a lesion of about 4cm-20cm in length.
•5.Written informed consent signed by the patients or representatives

Exclusion Criteria

•1.Previous bypass surgery or stent placement at the ipsilateral lower limb 2.History of intolerance to antiplatelet therapy, heparin, or contrast media. 3.Bleeding diathesis; 4.Active systemic bacterial infection; 5.Severely impaired renal function (serum creatinine level \> 2.5 mg/dL. Expected survival time of less than 24 months

Outcomes

Primary Outcomes

Coincidence rate of "5 points test of Tongji university"

Time Frame: 12 months

The primary study endpoint was that the coincidence rate of evaluating the microcirculation by the newly-established "5 points test of Tongji university" attains over 95% before and after operations as assessed by digital substraction angiography (DSA).