Optimized Strategy for Diabetic Patients With Critical Limb Ischemia(Part II) (DCLI-II) (DCLI-II)
|ClinicalTrials.gov Identifier: NCT01173094|
Recruitment Status : Unknown
Verified July 2010 by Liu Chang-wei, Peking Union Medical College Hospital.
Recruitment status was: Enrolling by invitation
First Posted : July 30, 2010
Last Update Posted : December 24, 2012
|Condition or disease||Intervention/treatment||Phase|
|Vascular Diseases Diabetes||Device: Percutaneous Transluminal Angioplasty Device: below-knee arterial bypass||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||130 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||DCLI-II:Optimized Strategy for Diabetic Patients With Critical Limb Ischemia: A Multi-center, Randomized Controlled Trial and Registration Study(Part II)|
|Study Start Date :||August 2010|
|Estimated Primary Completion Date :||July 2013|
|Estimated Study Completion Date :||July 2016|
The patients with short-obstruction in the below-knee artery will be included in this group.
Device: Percutaneous Transluminal Angioplasty
Before operation, take aspirin 100mg every day. During the operation, balloon is delivered by a catheter and positioned through the narrowing in the artery. Then expand the balloon against the wall of the blood vessel to provide a wider channel for blood.
The patients with long-obstruction in the below-knee artery will be included in this group.
Device: below-knee arterial bypass
Before operation, take aspirin 100mg every day. Perform bypass to below-knee(posterior tibial，anterior tibial or peroneal)arteries, saphenous vein graft with end to side anastomoses
- Occlusion of the below-knee artery 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01173094
|Peking Union Medical College Hospital|
|Beijing, Beijing, China, 100032|
|Xuanwu Hospital, Beijing|
|Beijing, Beijing, China, 100053|
|Beijing Tongren Hospital|
|Beijing, Beijing, China, Beijing|
|Study Chair:||Liu changwei, bachelor|