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临床试验/NCT03185052
NCT03185052已完成不适用

Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach

Nantes University Hospital10 个研究点 分布在 1 个国家目标入组 116 人开始时间: 2017年9月27日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
116
试验地点
10
主要终点
Total in-hospital admission rate

研究概览

简要总结

Over the past years, arterial closure systems have tended to replace manual compression to ensure hemostasis at femoral artery puncture points. Arterial closure systems reduce hemostasis and patient immobilization times, thus enabling early resumption of walking. These devices have contributed extensively to the development of outpatient stays for cardiology, vascular and neuro-radiology procedures.

According to certain studies however, it would appear that arterial closure devices do not present any greater benefits than manual compression in terms of hemostasis and complications. Moreover, the use of increasingly small diameter instruments would tend to render manual compression sufficient. Finally, the use of these devices generates additional costs.

The purpose of our prospective study is to evaluate the feasibility and safety of same-day discharge after manual compression in patients treated for peripheral artery disease by endovascular technique with 5F sheath.

详细描述

The reference management strategies for patients treated for peripheral arterial disease by endovascular technique are conventional hospitalization with manual compression and discharge after at least one over-night observation and outpatient hospitalization with the use of an arterial closure device. There are currently no official guidelines for guiding the patient towards one or other of these types of care. Indeed, outpatient management of artery disease is implemented in only a few centers in France. Several studies have shown that outpatient care is perfectly safe for patients. Our experiment at the Nantes University Hospital demonstrates also the reliability and safety of this care through the use of closure systems as shown by Albert. Now, it seems judicious to develop and improve this care since the use of smaller diameter devices would tend to render manual compression sufficient.

The method used is based on our previous protocols, routine practice and evaluation. First of all, patients eligible for same-day discharge are first selected according to SFAR (Société Française d'Anesthésie Réanimation - French Society for Anesthesia and Resuscitation) criteria for outpatients. Patients failing to meet these criteria are directed towards conventional hospitalization.

For outpatients, the patients are hospitalized in a specific unit hosting outpatients of different medico-surgical specialties. The paramedical team checks the prerequisites and the preoperative assessment. The use of a common femoral approach with 5F sheath is required. According to patients' needs, femoral anterograde or retrograde puncture are performed under duplex scan guidance. Aortoiliac and infrainguinal occlusive lesions are indifferently treated but the endovascular treatment must be compatible with the use of a stent or a drug coating balloon 5F sheath and 0.035 compatible..

The procedure should be finished 5h prior the outpatients unit closing to allow 5h follow-up. The intervention proceeded after an intravenous bolus of heparin. Anesthesia, antiplatelet regimen were let at the discretion of the interventionnalist. End-of-procedure hemostasis shall be implemented by the operator by manual compression for at least 10 minutes, potentially extended until complete hemostasis is achieved. A pressure pad shall be applied just after the end of manual compression.

The patient's general and local condition shall be monitored in the recovery room. If there are no local or general complications, the patient shall return to the ambulatory unit. In the unit, at H4, the compressive dressing is removed, patient is place in half-sitting position and without any complications, the ability to be discharged will be evaluated. The day after the operation, the patient is contacted by the ambulatory unit according with HAS and SFAR recommandations for a medical checkpoint. All of this will be conducted under medical and paramedical supervision. In the event of femoral puncture site active bleeding at any stage during care, the patient's surgeon will be notified and an additional manual compression will be applied if necessary. There are no specific guidelines concerning treatment with platelet aggregation inhibitors, whose choice will be left to the operator's discretion. In all cases, the treatments will be recorded.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age > 18 years,
  • Endovascular treatment by stent or drug coating balloon 5F and 0.035 compatible
  • Femoral approach
  • Outpatient hospitalization
  • Manual compression at puncture site
  • Rutherford 2 to 5
  • Patient affiliated with a social security scheme
  • Patient's signed informed consent form

排除标准

  • Under-age patient
  • Patient of age, but under legal guardianship or care
  • Contraindication to endovascular treatment
  • Use of a 6F or greater sheath
  • Radial or brachial puncture
  • Acute ischemia
  • Anticoagulant treatment or hemostasis disorder
  • Allergy to Elastoplast® type adhesive strips
  • Life expectancy of less than one month
  • Refusal of patient to participate in the study
  • Participation in another therapeutic trial
  • Pregnant woman, lactating women
  • Patients do not understand the French language or unfit for proposed follow in the study

结局指标

主要结局

Total in-hospital admission rate

时间窗: 1 month

Total in-hospital admission rate includes unplanned overnight surveillance and re-hospitalization rate at 1 month.

次要结局

  • Death (all causes) at 1 month.(1 month)
  • Unplanned overnight surveillance rate(1 month)
  • Clinical success at 1 month.(1 month)
  • Quality of life evaluation (EQ5D-3L) at 1 month.(1 month)
  • Time for groin compression and dressing.(1 month)
  • Re-hospitalization after discharge during M1(1 month)
  • Occurrence of major events during the perioperative period (H0 to M1)(1 month)
  • Technical success which is defined successful vascular access and completion of the endovascular procedure and immediate morphological success with less than 30% residual diameter reduction of the treated lesion on completion angiography.(1 month)
  • Economic analysis endpoints(1 month)
  • Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1)(1 month)
  • Occurrence of minor punctured femoral artery events during the perioperative period (H0 to M1), not requiring prolongation of hospitalization, repeat hospitalization or repeat surgery(1 month)
  • Freedom from target lesion revascularization (TLR) at 1 month.(1 month)
  • Freedom from target extremity revascularization (TER) at 1 month. TER is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target limb in surviving patients with preserved limb.(1 month)
  • Haemodynamic improvement: of ABI-values with 0.10 as compared to baseline values or to ABI inferior or egal 0.9 at 1-month without need for repeated TLR in surviving patients.(1 month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (10)

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