Absorbable Sutures in Vascular Surgery (ASPeVaS)

October 13, 2016 updated by: Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro

Absorbable Sutures in Peripheral Vascular Surgery

Absorbable sutures are not generally accepted by the majority of vascular surgeons for the possible complications such as the breakage of the suture at the anastomoses level. Some experimental and clinical studies in the current literature demonstrated that the use of absorbable sutures may even reduce some important complications such as restenosis.

The aim of this study is to compare absorbable and non-absorbable sutures in patients undergoing peripheral vascular surgery with vein bypass grafting.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Infrainguinal vein graft procedures may be performed, generally, on patients with critical limb ischemia (CLI) or popliteal artery aneurysm (PAA). Autologous vein graft, when adequate and available, is usually the preferred conduit, especially in the below knee vascular districts. Vein grafts may complicate with the onset of stenoses (up to 30% of cases). Such complications may develop, due to myointimal hyperplasia along the body of the graft or, more often, at the proximal or distal anastomoses where sutures are performed. In vascular surgery procedures, in case of arterial anastomoses, absorbable suture material is generally not preferred, mainly for the fear of breakage of the suture line. Previous experimental studies performed in animals and humans and a recent clinical study performed in humans on carotid surgery showed that absorbable sutures used in vascular surgery may even reduce the development of intimal hyperplasia and may reduce postoperative stenotic complications. The aim of this study is to evaluate the early and long-term results of absorbable sutures used in peripheral vascular surgery.

This is an open-label, parallel group study.

Patients undergoing vein bass grafting for CLI or PAA may be suitable for entry into ASPeVas trial. They must satisfy the following inclusion criteria:

Both sex. Age > 18 years old. Patients undergoing femoropopliteal or femorodistal vein bypass grafting; must be able to give informed consent; have no significant co-morbidity that makes life expectancy less than six months.

The randomisation process consists as follows: once a patient have consented entering the trial, an envelop is opened and the patient is offered the type of suture (absorbable or non absorbable) regardless of the surgical technique which is going to be performed (femoropopliteal or femorodistal vein bypass grafting).

All patients have to be followed-up, the day after the operation (time 0) and then subsequently at 1, 3,6,9,12 and 18 months.

At each appointment, Ankle Brachial Pressure Index (ABPI) is measured and then Duplex scanning (DS) is performed. In particular, by means of DS the peak systolic flow velocity (PSFV) at multiple sites along the entire graft is measured. A graft at risk of failure was defined as having a PSFV < 45 cm/s or a ratio of V2 (peak velocity at the site of the stenosis) to V1 (peak systolic velocity at any other point within 2 cm at the normal adjacent graft) > 2. Any other irregularities, such as inflow/outflow problems, graft dilatation will be also recorded.

Clinical signs of a failing graft will be collected: disabling claudication, ischemic pain, ischemic ulcers.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Raffaele Raffaele, Raffaele
  • Phone Number: +393387078043
  • Email: rserra@unicz.it

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

inclusion criteria:

  • Patients undergoing femoropopliteal or femorodistal vein bypass grafting;
  • Patients able to give informed consent;
  • Patients having no significant co-morbidity that makes life expectancy less than six months.

exclusion criteria:

  • patients that do not meet the aforementioned criteria.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Absorbable Group
In this group of patients absorbable sutures will be used for vascular anastomoses.
Procedure: Absorbable suture
Vascular anastomoses will be performed with absorbable materials
Experimental: Non-Absorbable Group
In this group of patients non-absorbable sutures will be used for vascular anastomoses.
Procedure: Non-Absorbable suture
Vascular anastomoses will be performed with non-absorbable materials

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Flow Velocity in the graft
Time Frame: 18 months
centimeters per second (cm/sec)
18 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Catanzaro

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raffaele Serra, M.D., PhD., University Magna Graecia of Catanzaro
  • Study Chair: Stefano de Franciscis, M.D., University Magna Graecia of Catanzaro

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2016

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2017

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 13, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 17, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ER.ALL.2016.02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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