Peripheral Vascular DiseaseASPeVaSNCT02935127
Absorbable Sutures in Vascular Surgery
A study testing Absorbable suture and Non-Absorbable suture in people with Peripheral Vascular Disease, run by University of Catanzaro.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Vascular Disease
- What is being tested?
- Absorbable suture and Non-Absorbable suture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to May 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- patients that do not meet the aforementioned criteria.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Peripheral Vascular Disease
- Being tested
- Absorbable suture, Non-Absorbable suture
- Keywords
- absorbable sutures
- Medical subject headings
- Peripheral Vascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Absorbable sutureProcedure or surgery
Vascular anastomoses will be performed with absorbable materials
Non-Absorbable sutureProcedure or surgery
Vascular anastomoses will be performed with non-absorbable materials
| Study group | Role | What they receive |
|---|---|---|
| Absorbable Group | Experimental | In this group of patients absorbable sutures will be used for vascular anastomoses. Receives: Procedure: Absorbable suture |
| Non-Absorbable Group | Experimental | In this group of patients non-absorbable sutures will be used for vascular anastomoses. Receives: Procedure: Non-Absorbable suture |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Velocity in the graft
centimeters per second (cm/sec)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2016 (estimated)
- Study startNov 2016
- Primary completionApr 2017 (estimated)
- Study completionMay 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Peripheral Vascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Catanzaro
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Raffaele Serra, MD, Ph.D., University of Catanzaro
- Investigators
- Raffaele Serra, M.D., PhD., Principal investigator, University Magna Graecia of CatanzaroStefano de Franciscis, M.D., Study chair, University Magna Graecia of Catanzaro
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935127
- Sponsor's protocol ID
- ER.ALL.2016.02
- Acronym
- ASPeVaS
- Status last verified
- Oct 2016
- First submitted
- 13 Oct 2016
- Last updated
- 17 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Gasbarro V, Traina L, Mascoli F, Coscia V, Buffone G, Grande R, Fugetto F, Butrico L, de Franciscis S, Serra R. Absorbable suture material in carotid surgery. Vasa. 2015 Nov;44(6):451-7. doi: 10.1024/0301-1526/a000468.
PubMed 26515222
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Absorbable Sutures in Peripheral Vascular Surgery
- ClinicalTrials.gov ID
- NCT02935127
- Acronym / sponsor ID
- ASPeVaS / ER.ALL.2016.02
- Conditions
- Peripheral Vascular Disease
- Keywords
- absorbable sutures
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of CatanzaroUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Apr 2017 (estimated)
- Study completion
- May 2018 (estimated)
- First posted
- 17 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Absorbable Group | Experimental | Procedure: Absorbable sutureIn this group of patients absorbable sutures will be used for vascular anastomoses. |
| Non-Absorbable Group | Experimental | Procedure: Non-Absorbable sutureIn this group of patients non-absorbable sutures will be used for vascular anastomoses. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- patients that do not meet the aforementioned criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Absorbable sutureVascular anastomoses will be performed with absorbable materials | Procedure or surgery | Absorbable Group |
| Non-Absorbable sutureVascular anastomoses will be performed with non-absorbable materials | Procedure or surgery | Non-Absorbable Group |
Primary outcome
Flow Velocity in the graft
Time frame: 18 months
centimeters per second (cm/sec)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2016.
- Background: PubMed 26515222Gasbarro V, Traina L, Mascoli F, Coscia V, Buffone G, Grande R, Fugetto F, Butrico L, de Franciscis S, Serra R. Absorbable suture material in carotid surgery. Vasa. 2015 Nov;44(6):451-7. doi: 10.1024/0301-1526/a000468.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raffaele Serra, M.D., PhD. principal investigator
University Magna Graecia of Catanzaro
Stefano de Franciscis, M.D. study chair
University Magna Graecia of Catanzaro
Questions about this trial
What is this clinical trial studying?
A study testing Absorbable suture and Non-Absorbable suture in people with Peripheral Vascular Disease, run by University of Catanzaro.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Raffaele Raffaele, Raffaele (+393387078043, rserra@unicz.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Flow Velocity in the graft (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02935127, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Oct 2016; AzTrials last refreshed its copy on 5 Nov 2026.