Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part I) (DCLI-I)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01171703|
Recruitment Status : Unknown
Verified July 2010 by Liu Chang-wei, Peking Union Medical College Hospital.
Recruitment status was: Enrolling by invitation
First Posted : July 28, 2010
Last Update Posted : December 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Vascular Diseases Diabetes||Device: femoral-popliteal bypass Device: stent||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part I)|
|Study Start Date :||November 2010|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2016|
Device: femoral-popliteal bypass
Before operation, take aspirin 100mg every day. Groin and suprageniculate incision, PTFE graft with end to side anastomoses.
Before operation, take aspirin 100mg every day. During the operation, stent is delivered by a catheter and positioned through the narrowing in the artery. The stent is then expanded against the wall of the blood vessel to provide a wider channel for blood. At last, use balloon dilate the stent.
- Occlusion of the stent or bypass [ Time Frame: 36 months ]
- Mortality [ Time Frame: 30 days ]The number of death during the first month after procedure, no matter whether the cause of death is related to the procedure.
- Rate of limb salvage [ Time Frame: 36 months ]
- Procedural complications, defined as any adverse event [ Time Frame: 36 months ]including MI, DVT, hematoma, renal failure, wound infection, lymphatic fistula
- Quality of Life assessment [ Time Frame: 36 months ]assessment in 1 month,6 months,12 months,24 months and 36 months post procedure
- Restenosis measured by Duplex Ultrasound or CTA [ Time Frame: 36 months ]
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): NCT01171703
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|Xuanwu Hospital, Beijing|
|Beijing, Beijing, China, 100053|
|Beijing Tongren Hospital|
|Beijing, Beijing, China, 100730|
|Study Chair:||Liu changwei, bachelor|