Randomized trial comparing effectiveness and safety of three percutaneous arterial closure devices vs manual compression in peripheral interventions
| ISRCTN | ISRCTN55240225 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN55240225 |
| Secondary identifying numbers | PACD1 |
- Submission date
- 30/07/2017
- Registration date
- 01/08/2017
- Last edited
- 14/09/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims
Peripheral arterial disease is a condition where fatty deposits build up in the arteries and restrict the blood supply to the leg muscles. Endovascular interventions (procedures that are done inside the blood vessels) have recently become the procedure of choice, in most cases, for the diagnosis and treatment of peripheral arterial disease. Over 5,000 endovascular procedures are performed annually in Spain for the diagnosis and treatment of PAD. An arterial access is required to perform these procedures. At first this was obtained by surgical dissection, but nowadays this step is avoided in most of cases thanks to the development of percutaneous techniques, where access is achieved through needle-puncture of the skin. Despite the advantages, these techniques pose other associated problems such as those related to the arterial puncture and stopping bleeding at the end of the procedure. After the procedure there are different arterial closure strategies that include direct manual compression over the puncture site, the use of mechanical devices to assist compression and, more recently, the use of percutaneous arterial closure devices. There are several mechanisms of action for these devices, and the most widely used are the collagen plug, percutaneous sutures and hemostatic clips. The use of these systems involves a risk of complications resulting from lack of effectiveness at stopping bleeding and inadequate delivery of the device. The available scientific evidence concerning these devices is scarce and of poor quality in many cases, with most results based on diagnostic procedures performed on the coronary (heart) arteries, which are not applicable to interventions performed on peripheral arteries. The aim of this study is to demonstrate that percutaneous arterial closure devices reduce the time needed to stop bleeding after percutaneous arterial access procedures performed on peripheral arteries, without decreasing the effectiveness and without increasing the risk of complications compared with manual compression.
Who can participate?
Patients aged over 18 undergoing percutaneous arterial access procedures for the diagnosis or treatment of peripheral arterial disease
What does the study involve?
Once the percutaneous arterial access procedure is finished, participants are randomly allocated to one of the following procedures to stop bleeding: collagen plug, metallic clip, suture mediated, or manual compression at the puncture site for at least 10 minutes and for additional periods of 5 minutes until bleeding stops. The effectiveness of the procedures is assessed by observing the absence of bleeding through the puncture site. The time needed to completely stop the bleeding is measured. The occurrence of complications related to the arterial puncture is assessed by physical examination and ultrasound performed 24 hours and 1 month after the intervention.
What are the possible benefits and risks of participating?
The results of this study can help to find out whether these devices are safe and effective in patients with peripheral arterial disease, who usually have more diseased arteries which are more complicated to puncture and have a higher risk of complications. If these devices can be safely used, many patients will have a better recovery with shorter hospital stays and will be able to walk sooner. The possible risks of these devices are acute arterial occlusion (blockage), infection, bleeding and/or hematoma (a solid swelling of clotted blood).
Where is the study run from?
Hospital Virgen de la Salud de Toledo (Spain)
When is the study starting and how long is it expected to run for?
January 2012 to June 2014
Who is funding the study?
Hospital Virgen de la Salud de Toledo (Spain)
Who is the main contact?
Dr Javier Peinado Cebrina
Contact information
Public
C/ Lepanto 20
Nambroca (Toledo)
45190
Spain
 ORCID ID |
0000-0001-6062-0031 |
|---|
Study information
| Study design | Interventional prospective randomized controlled non-masked single-centre trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Effectiveness and safety of three percutaneous arterial closure devices (collagen plug, metallic clip and suture mediated) compared to manual compression in hemostasis after percutaneous transfemoral arterial procedures in peripheral territories |
| Study objectives | Percutaneous arterial closure devices achieve hemostasis in the arterial femoral access faster than standard manual compression, without increasing the risk of complications related to arterial access site and improving the comfort of the patients. |
| Ethics approval(s) | Ethics committee of clinical research (Comité ético de investigación clínica) of the Complejo Hospitalario de Toledo, 18/01/2012, ref: 82 |
| Health condition(s) or problem(s) studied | Peripheral arterial disease |
| Intervention | Patients are assigned randomly, by means of a computer generated number, at the end of the procedure to receive hemostasis of the femoral arterial access site with one of the three arterial closure devices tested (collagen plug [Angioseal], metallic clip [Starclose] or suture mediated [Perclose ProGlide]) or manual compression at the puncture site for at least 10 minutes and for additional periods of 5 minutes until complete hemostasis is achieved. Effectiveness of the hemostatic procedures will be assessed by observation of the absence of bleeding through the puncture site. Time necessary to achieve complete hemostasis will be measured. Occurrence of any complication related to the arterial puncture will be assessed by physical examination and ultrasonography performed 24 hours and 1 month after the intervention. |
| Intervention type | Mixed |
| Primary outcome measure | Effectiveness of the hemostatic procedure applied, assessed by observation of the absence of bleeding through the puncture site immediately after the application of the hemostatic system, 24 hours later and 1 month later |
| Secondary outcome measures | Occurrence of complications related to arterial access site, assessed by postprocedure physical examination, echo doppler at the arterial access, and blood test at 24 hours and 1 month post intervention |
| Overall study start date | 01/01/2012 |
| Completion date | 30/06/2014 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 120 |
| Key inclusion criteria | 1. Patients intervened percutaneously for treatment or diagnostic of peripheral arterial disease through femoral access in the Department of Angiology and Vascular Surgery of the Hospital Virgen de la Salud de Toledo 2. Aged over 18 |
| Key exclusion criteria | 1. Known contraindications for any of the percutaneous arterial closure devices tested 2. Deny of the patient to sign the informed consent document |
| Date of first enrolment | 01/06/2012 |
| Date of final enrolment | 30/06/2014 |
Locations
Countries of recruitment
- Spain
Study participating centre
45003
Spain
Sponsor information
Hospital/treatment centre
Department of Angiology and Vascular Surgery
Avenida de Barber 30
Toledo
45003
Spain
"ROR" |
https://ror.org/0289cxp23 |
|---|
Funders
Funder type
Hospital/treatment centre
No information available
Results and Publications
| Intention to publish date | 01/09/2017 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Intended to be published in an international scientific journal in September 2017. |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Javier Peinado Cebrina. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/11/2018 | 14/09/2020 | Yes | No |
Editorial Notes
14/09/2020: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
