Peripheral Vascular Disease in Diabetes Clinical Trial
Official title:
Evaluation of Microcirculation of Peripheral Vascular Disease in Diabetes
The main aim of the present study was to evaluate the microcirculation of peripheral vascular disease in diabetes.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | July 31, 2018 |
| Est. primary completion date | July 31, 2018 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - 1.Patients with Peripheral vascular disease with or without diabetes. 2.Rutherford class 2-6. 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 |
| Country | Name | City | State |
|---|---|---|---|
| China | Shanghai Tenth People's Hospital, Tong ji University | Shanghai |
| Lead Sponsor | Collaborator |
|---|---|
| Shanghai 10th People's Hospital |
China,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Coincidence rate of "5 points test of Tongji university" | 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). | 12 months |