An interventional study of Manual puncture point compression in Peripheral Arterial Disease, sponsored by Nantes University Hospital. Completed at 10 sites in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-11-21.
Sponsored by Nantes University Hospital · Not applicable, Interventional, and Other
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.
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.
1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.
This study's enrollment of 116 is above the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.
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Exclusion Criteria:
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Other: Manual puncture point compression
Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter
Total in-hospital admission rate
Total in-hospital admission rate includes unplanned overnight surveillance and re-hospitalization rate at 1 month.
Time frame: 1 month
Death (all causes) at 1 month.
Time frame: 1 month
Unplanned overnight surveillance rate
Time frame: 1 month
Re-hospitalization after discharge during M1
Time frame: 1 month
Occurrence of major events during the perioperative period (H0 to M1)
Occurrence of major events during the perioperative period (H0 to M1) (MACE: Major Adverse Cardiovascular Event, MALE: Major Adverse Limb Event)
Time frame: 1 month
Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1)
Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1), requiring prolongation of hospitalization, repeat hospitalization or repeat surgery (hematoma, hemorrhage, false aneurysm, arterio-venous fistula, infection...).
Time frame: 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
Time frame: 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.
Time frame: 1 month
Time for groin compression and dressing.
Time frame: 1 month
Freedom from target lesion revascularization (TLR) at 1 month.
TLR expresses the frequency of the need for repeated procedures (endovascular or surgical) due to a problem arising from the treated lesion in surviving patients with preserved limb.
Time frame: 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.
Time frame: 1 month
Clinical success at 1 month.
Clinical success is defined by defined as a sustained upward shift of 1 category of the Rutherford classification for claudicants and by wound healing and rest pain resolution for patients in CLI, without the need for repeated TLR in surviving patients.
Time frame: 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.
Time frame: 1 month
Quality of life evaluation (EQ5D-3L) at 1 month.
Time frame: 1 month
Economic analysis endpoints
Resources consumed will be recorded from the intervention to one month post-operatively. We will collect hospital resources consumed (length of procedures, operative room staff, medical device used in case of manual compression's failure, hospitalizations due to complications...) and office-based care resources (medical and paramedical consultations, caregivers).
Time frame: 1 month
Plan to share: No
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Nantes University Hospital