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

NCT03185052 | Completed

• 1 other identifier: RC16_0384
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 10

Brief Summary

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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Total in-hospital admission rate

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

  1 month

Secondary Outcomes (14)

• Death (all causes) at 1 month.

  1 month

• Unplanned overnight surveillance rate

  1 month

• Re-hospitalization after discharge during M1

  1 month

• Occurrence of major events during the perioperative period (H0 to M1)

  1 month

• Occurrence of major punctured femoral artery events during the perioperative period (H0 to M1)

  1 month

Study Arms (1)

Manual puncture point compression

OTHER

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

Interventions

Manual puncture point compression OTHER

Manual puncture point compression following a diagnostic or therapeutic procedure by endovascular technique involving retrograde femoral puncture point with 5F guide catheter

Manual puncture point compression

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (10)

CHU de Besançon

Besançon, France

Location

CHU de Bordeaux

Bordeaux, France

Location

AP-HP, Hôpital Ambroise Paré

Boulogne-Billancourt, France

Location

CHU de Clermont Ferrand

Clermont-Ferrand, France

Location

CHU de DIJON

Dijon, France

Location

Clinique de Fontaine-Les- Dijon

Dijon, France

Location

Nantes University Hospital

Nantes, France

Location

AP-HP, Hôpital Européen Georges Pompidou

Paris, France

Location

Institut Mutualiste Montsouris

Paris, France

Location

Clinique de l'Europe

Rouen, France

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2017
• First Posted: June 14, 2017
• Study Start: September 27, 2017
• Primary Completion: October 10, 2019
• Study Completion: October 10, 2019
• Last Updated: November 21, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10)