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).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 344
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
In 2000, the Trans Atlantic Inter-Society Consensus (TASC) stated that patients with CLI should be treated with revascularization, to provide sufficient blood flow to relieve the rest pain and heal skin lesions. TASC also suggested that the best procedure should avoid a general anaesthesia, pose a lesser systemic stress and have fewer serious complications.
All these considerations pose peripheral angioplasty (PTA) as the procedure of choice, when feasible.
Unfortunately, TASC Recommendations, published in 2000 and confirmed in 2007, use morphological criteria to define guidelines for the choice of revascularization procedure.
According to these recommendations, type C and D lesions, which comprise most serious stenosis and occlusions, affecting long tracts of vessels, are candidate to bypass interventions, more than PTA.
This choice was due to the first impression, then denied by BASIL study, that PTA could be affected by a reduced efficacy on limb salvage.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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)
排除标准
- •Cancer with adverse prognosis in months, or chemotherapeutic treatment
- •Ongoing or planned pregnancy
- •Lack of consent to participate to the study