Femoral Artery OcclusionNCT00810134
Bypass or Thurpass for Superficial Femoral Artery Occlusion? Scandinavian Thurpass Study
A study testing Thrupass and Bypass in people with Femoral Artery Occlusion, run by University of Helsinki at 1 site in Finland.
Trial summary
The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Femoral Artery Occlusion
- What is being tested?
- Thrupass and Bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteFinland
- Study dates
- Jan 2003to Apr 2008
- 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
- Superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint.
- Patient must be equally eligible for both procedures.
- Patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia.
- Normal adjacent vessel diameter must be between 4.8 and 6.5 mm.
- At least one patent distal run-off vessel and at least 1 cm of healthy superficial femoral artery below and above the lesion to allow proper placement of the endoprosthesis.
- Patient must be 18 years or older.
- Women of childbearing age must have negative pregnancy test prior to inclusion.
Who cannot join
- Known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants.
- Bleeding diatheses
- Presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment.
- Planned other endovascular therapy of the same segment.
- Other than 6-7 mm diameter endoprosthesis or 6 mm PTFE-prosthesis is needed.
- Presence of evolving malignant cancer or any other illness posing an immediate threat to life.
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- Life-expectancy less than 2 years due to co-morbidity or other situation that would make the patient unlikely candidate for follow-up visits.
- Participation in another vascular clinical study less than 30 days prior to inclusion.
- Patients unable to fill out the prescribed quality of life questionnaires themselves or unable to understand the full meaning of the informed consent.
Trial locations and contacts
1 site in 1 country.
Finland1 site
Department of Vascular Surgery, Helsinki University Central Hospital
Helsinki, 00029
About this study
Official title: A Randomised Controlled Trial for the Treatment of 5 - 25 cm Superficial Femoral Artery oc-Clusions Comparing Femoropopliteal Bypass With 6 mm PTFE-Prosthesis and 6 - 7 mm Viabahn Endoprosthesis
The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. The primary objective is to compare primary patencies of the two treatments. The secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.
Read the detailed description
Femoropopliteal bypass graft surgery with PTFE-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral artery occlusion. Preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment.
A randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. Patients are treated either with Viabahn thrupass endoprosthesis (Gore corp.) or with 6 mm PTFE-prosthesis bypass graft surgery. Primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.
- Conditions
- Femoral Artery Occlusion
- Being tested
- Thrupass, Bypass
- Keywords
- Superficial femoral artery occlusion (TASC II B or C)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ThrupassProcedure or surgery
Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis.
BypassProcedure or surgery
Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft
| Study group | Role | What they receive |
|---|---|---|
| Thrupass | Other | Endovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis. Receives: Procedure: Thrupass |
| Bypass | Other | Surgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft Receives: Procedure: Bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary end point of the study will be primary patency. Patency should be demonstrated by duplex ultrasound or other imaging modality at every control visit. ABI measurements will be recorded to assess the haemodynamic effect of the procedure.
Measured: At three years after intervention
Secondary outcomes (6)
Suboptimal outcome is defined as the presence of any of the following: re-stenosis diagnosed by colour duplex ultrasonography, ankle-brachial index improvement of less than 0.15, or re-intervention at the treated site.
Measured: At any time of the study
Secondary patency is defined by procedures required to re-establish or maintain blood flow after occlusion.
Measured: At any time of the study
Complications will include post procedure haemorrhage, haematomas, cardiac, pulmonary and renal complications and infection. Technical problems or equipment failure in the endoprosthesis group will also be recorded.
Measured: At any time of the study
A procedural death will be any death that will occur within 30 days of the procedure.
Measured: At any time of the study
Immediate functional failure is one in which the threshold increase of ABI is not achieved within 24 hours. Early failure is any failure occurring within 30 days of the operation.
Measured: within 30 days of the operation
Limb salvage is defined as retention of the leg without any major amputation or death.
Measured: At any time of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2008 (estimated)
- Study startJan 2003
- Primary completionFeb 2008
- Study completionApr 2008
Why it stopped: Due to the results of interim analysis at the time 44 patients were recruited.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Femoral Artery OcclusionStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Helsinki
- Sponsor type
- University, hospital or other
- Collaborators
- W.L.Gore & Associates
- Investigators
- Mauri Lepantalo, M.D., PhD, Principal investigator, Department of Vascular Surgery, Helsinki University Central Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00810134
- Sponsor's protocol ID
- Version 1.7 - Oct 15th 2002
- Status last verified
- Dec 2008
- First submitted
- 15 Dec 2008
- Last updated
- 17 Dec 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial for the Treatment of 5 - 25 cm Superficial Femoral Artery oc-Clusions Comparing Femoropopliteal Bypass With 6 mm PTFE-Prosthesis and 6 - 7 mm Viabahn Endoprosthesis
- ClinicalTrials.gov ID
- NCT00810134
- Acronym / sponsor ID
- Version 1.7 - Oct 15th 2002
- Conditions
- Femoral Artery Occlusion
- Keywords
- Superficial femoral artery occlusion (TASC II B or C)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Due to the results of interim analysis at the time 44 patients were recruited.
- Enrolment
- 44 participants (actual)
- Lead sponsor
- University of HelsinkiUniversity, hospital or other
- Collaborators
- W.L.Gore & Associates
- Study start
- Jan 2003
- Primary completion
- Feb 2008 (actual)
- Study completion
- Apr 2008 (actual)
- First posted
- 17 Dec 2008 (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.
The aim of the study is to compare PTFE-graft bypass surgery versus Viabahn endoprosthesis for femoropopliteal arterial occlusion in intermittent claudication and critical ischaemia in patients who would be technically amenable for both treatments. The primary objective is to compare primary patencies of the two treatments. The secondary objective of the study is to evaluate secondary patency, functional status, the quality of life and costs of the new endovascular therapy.
Detailed description
Femoropopliteal bypass graft surgery with PTFE-prosthesis has proven to be an acceptable treatment for stable incapacitating claudication and critical ischaemia in patients with superficial femoral artery occlusion. Preliminary results of a thrupass endoprosthesis in the treatment of femoral lesions are promising. Less morbidity and better cost-effectiveness are suggested to be achieved in treatment of chronic lower limb ischaemia with endovascular treatment comparing to surgical treatment.
A randomised multicentre trial aims to enrol a pilot group of 60 + 60 patients to be followed for 3 years. Patients are treated either with Viabahn thrupass endoprosthesis (Gore corp.) or with 6 mm PTFE-prosthesis bypass graft surgery. Primary patency at three years is the primary end point and secondary patency, functional success, costs and quality of life are the secondary end points.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Thrupass | Other | Procedure: ThrupassEndovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis. |
| Bypass | Other | Procedure: BypassSurgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Superficial femoral artery occlusion from 5 to 25 cm in length above the knee joint.
- Patient must be equally eligible for both procedures.
- Patient must present intermittent claudication with resistance to medical therapy and exercise or critical ischaemia.
- Normal adjacent vessel diameter must be between 4.8 and 6.5 mm.
- At least one patent distal run-off vessel and at least 1 cm of healthy superficial femoral artery below and above the lesion to allow proper placement of the endoprosthesis.
Key exclusion criteria (9 listed)
- Known allergy or contraindications to aspirin, clopidogrel, dipyridamole or anticoagulants.
- Bleeding diatheses
- Presence of one or several previously placed endoprosthesis or grafts in the superficial femoral artery segment.
- Planned other endovascular therapy of the same segment.
- Other than 6-7 mm diameter endoprosthesis or 6 mm PTFE-prosthesis is needed.
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 |
|---|---|---|
| ThrupassEndovascular treatment (Thrupass) is performed as a femoropopliteal above knee endovascular recanalisation and Viabahn introduction with 6-7 mm Viabahn endo-prosthesis. | Procedure or surgery | Thrupass |
| BypassSurgical procedure is performed as a femoropopliteal above knee by-pass with 6 mm non-coated PTFE-graft | Procedure or surgery | Bypass |
Primary outcome
Primary end point of the study will be primary patency. Patency should be demonstrated by duplex ultrasound or other imaging modality at every control visit. ABI measurements will be recorded to assess the haemodynamic effect of the procedure.
Time frame: At three years after intervention
6 secondary outcomes
Suboptimal outcome is defined as the presence of any of the following: re-stenosis diagnosed by colour duplex ultrasonography, ankle-brachial index improvement of less than 0.15, or re-intervention at the treated site.
Time frame: At any time of the study
Secondary patency is defined by procedures required to re-establish or maintain blood flow after occlusion.
Time frame: At any time of the study
Complications will include post procedure haemorrhage, haematomas, cardiac, pulmonary and renal complications and infection. Technical problems or equipment failure in the endoprosthesis group will also be recorded.
Time frame: At any time of the study
A procedural death will be any death that will occur within 30 days of the procedure.
Time frame: At any time of the study
Immediate functional failure is one in which the threshold increase of ABI is not achieved within 24 hours. Early failure is any failure occurring within 30 days of the operation.
Time frame: within 30 days of the operation
Limb salvage is defined as retention of the leg without any major amputation or death.
Time frame: At any time of the study
Results and safety
The study was stopped early (reason given: Due to the results of interim analysis at the time 44 patients were recruited.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2008.
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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.
Mauri Lepantalo, M.D., PhD principal investigator
Department of Vascular Surgery, Helsinki University Central Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Thrupass and Bypass in people with Femoral Artery Occlusion, run by University of Helsinki at 1 site in Finland.
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 7 inclusion and 9 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: stopped early, as of the sponsor's last update on 17 Dec 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was stopped early (reason given: Due to the results of interim analysis at the time 44 patients were recruited.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary end point of the study will be primary patency. Patency should be demonstrated by duplex ultrasound or other imaging modality at every control visit. ABI measurements will be recorded to assess the haemodynamic effect of the procedure. (time frame: At three years after intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Dec 2008.