Stable Claudication (Fontaine IIa and IIb)NCT01230229
Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
A study testing Stenting and Best medical treatment in people with Stable Claudication (Fontaine IIa and IIb) and Superficial Femoral Artery Disease, run by Lund University at 2 sites in Sweden.
Trial summary
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment
- What is being tested?
- Stenting and Best medical treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 2 sitesSweden
- Study dates
- Jan 2010to Aug 2017
- 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
- Age > 18 years
- Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study.
- Patient suffering from stable claudication (Fontaine IIa and IIb).
- One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA.
- Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA.
- Patient is willing and able to comply with the specified follow-up evaluation
- The patient or legally authorized representative must provide written informed consent prior to the procedure.
Who cannot join
- Recent hemorrhagic stroke (within past 3 months)
- Aneurysm in the SFA or popliteal artery
- Previously implanted stent(s) in the to be treated artery at the same site
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
- Revascularisation involving the same limb 30 days prior to the index procedure or a planned revascularisation within 30 days after the index procedure
Show all 10Show fewer
- 8.Critical Limb Ischemia in the index leg (Fontaine III and IV). 9.Requirement of stent placement in the popliteal artery. For the purpose of this protocol all lesions are to be located at least three centimetres proximal to the superior edge of the patella.
- 10.Life expectancy of less than 24 months or other factors making clinical follow-up difficult 11.Patients enrolled in this or other clinical trial or anticipated to be included into a trial, without written approval of principal investigator of this study.
- 12.Walking capacity more than 500 meters.
- -
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
Dept of Radiology, Helsingborg Hospital
Helsingborg, S-251 87
Department of Vascular Disease, Skåne University Hospital
Malmö, S-205 02
About this study
The aim of this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
Read the detailed description
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene. Treatment options include a) conservative measures, with attention to medical risk factors, smoking cessation and exercise programmes, b) minimally invasive treatments such as angioplasty and c) surgical procedures such as femoro-popliteal bypass grafts.
Percutaneous transluminal angioplasty (PTA) has been widely used in the treatment of femoro-popliteal stenosis and occlusion for many years. However, the medium and long-term results have always been suboptimal due to a high rate of restenosis.
With restenosis rates of 70 % with PTA alone in long SFA lesions. Factors which contribute to poor results include the presence of occlusion rather than stenosis, the length of the lesion and the severity of run-off vessel disease.(1)
Stents are expandable metal mesh tubes which are widely used in the treatment of arterial disease in the coronary, renal and iliac arteries, where they have been shown to have superior patency to balloon angioplasty alone.
In the treatment of SFA lesions several early studies have investigated the patency of balloon expandable stents. These are stents with low flexibility and high risk of deformation in SFA. Medium and long-term results are not better than with PTA alone.(2)
Self expanding nitinol stents are stents generally with high flexibility and moderate to high radial force. Initial studies have shown promising results in the SFA.(3)
Early prospective randomised studies , the Sirocco I and II study show as low as 7 % restenosis rate at 6 months and 18% at 12 months self expanding nitinol stent.(4, 5) Later studies have focused on the issue of the correlation of stent fractures and low patency. These have shown that higher restenosis rates correlated to the length of the stented segment, number of stents and stent brand (6)
Up to now the most frequent use of stents in the SFA is "bailout" stenting. Investigated in a prospective randomised trial on patients with severe claudication or critical ischemia with long lesions (130 +- 60 mm) primary stenting in the SFA is showing superior results to PTA with bailout stenting on restenosis rate, ABI and walking distance.(7) There are for the moment two more trials investigating the results of direct stenting.
The FAST trial investigated claudicants with short lesions (4,5 cm); the stent arm used Luminexx stents versus PTA alone with no significant in difference in patency between both treatment arms after 12 months follow up.(8) The Resilient trial investigated patients with claudication and critical limb ischemia with 6,5 cm long lesions. The results are not published, but positive "pre hand" information has already come out. (9)
The most accepted treatment in claudicants is conservative best medical treatment with or without supervised walking training.(10) There is a trend to stent treatment in certain situations.
There are to the best of our knowledge no studies comparing direct stenting with conservative treatment in claudicants.
The aim of this study is to evaluate whether primary stenting with nitinol self expanding stent in patients suffering from stable claudication (Fontaine IIa and IIb) due to superficial femoral artery disease, results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys. Patients will be followed up 24 months after treatment.
A secondary objective is to study the impact of primary stenting versus conservative treatment on ABI and Walking Distance development during the 24 month follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months.
12 month follow-up data have been published in Eur J Vasc Endovasc Surg 2017;53:686-694. All 24 month follow-up data have been collected, and a manuscript is in preparation.
- Conditions
- Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment, Quality of Life Scores at 12 and 24 Months
- Being tested
- Stenting, Best medical treatment
- Keywords
- Intermittent claudication, Superficial femoral artery, Stenting, Medical treatment, Quality of life
- Medical subject headings
- Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
StentingProcedure or surgery
Also called Endovascular treatment of claudication
The stent should be deployed percutaneously, appropriate stent(s) size selected based upon the angiogram. The diameter must be 1-2 mm larger than the vessel. Length is chosen to cover lesion with one stent if possible. The choice of brand will be made through random selection among those offering possibility to cover the lesion with one stent. If more than one stent is required, overlap between 0.5 and 1 cm is acceptable. Postdilatation must be performed with a PTA balloon shorter than the length and less than the diameter of the stent. An angiogram should be made to compare the pre- and post-implant minimum lumen diameters. The non-diseased artery diameters shall be measured and residual % stenosis calculated.
Best medical treatmentOther
Also called Medical treatment of intermittent claudication
Patients randomised to conservative treatment will receive appropriate medication with target levels of cholesterol 4,5 mmol/l, LDL 2,5 mmol/l and blood pressure level of 130/80 mmHg in addition to instruction how to engage in an exercise program. Each patient will receive a 'step-meter' which has to be carried during all activity during the first month and then during one week before each follow up visit. Step-meter read-outs will be recorded during each follow up visit. Smokers will be actively advised to quit smoking.
| Study group | Role | What they receive |
|---|---|---|
| Stenting | Active comparator | Active treatment group Receives: Procedure: Stenting |
| Conservative treatment | Placebo comparator | Best medical treatment Receives: Other: Best medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in Quality of Life scores
Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys
Measured: 12 months
Secondary outcomes (1)
Ankle/Brachial Index (ABI) and Walking Distance
Ankle/Brachial Index (ABI) and walking distance development during the follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2010 (estimated)
- Study startJan 2010
- Primary completionJul 2017
- Study completionAug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Stable Claudication (Fontaine IIa and IIb)Studies of the same condition, open and under way.
- More trials run by Lund UniversityThe sponsor's other registered studies.
- 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 (actual)
Sponsor and investigators
- Lead sponsor
- Lund University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anders Gottsater, Lund University
- Investigators
- Hans Lindgren, MD, Principal investigator, Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01230229
- Sponsor's protocol ID
- SFA stenting and QoL
- Status last verified
- Aug 2017
- First submitted
- 28 Oct 2010
- Last updated
- 23 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Lindgren H, Qvarfordt P, Akesson M, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial. Eur J Vasc Endovasc Surg. 2017 May;53(5):686-694. doi: 10.1016/j.ejvs.2017.01.026. Epub 2017 Mar 31.
PubMed 28372983Lindgren HIV, Qvarfordt P, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2018 Jun;41(6):872-881. doi: 10.1007/s00270-018-1925-0. Epub 2018 Mar 8.
PubMed 29520431
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Stenting vs Conservative Treatment in Claudicants - a Study on Quality of Life
- ClinicalTrials.gov ID
- NCT01230229
- Acronym / sponsor ID
- SFA stenting and QoL
- Conditions
- Stable Claudication (Fontaine IIa and IIb), Superficial Femoral Artery Disease, Best Medical Treatment, Quality of Life Scores at 12 and 24 Months
- Keywords
- Intermittent claudication, Superficial femoral artery, Stenting, Medical treatment, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Lund UniversityUniversity, hospital or other
- Study start
- Jan 2010 (actual)
- Primary completion
- Jul 2017 (actual)
- Study completion
- Aug 2017 (actual)
- First posted
- 29 Oct 2010 (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 this study is to evaluate whether primary stenting with self expanding stent in patients with peripheral arterial disease suffering from stable claudication due to superficial femoral artery disease results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using established surveys. Patients will be followed up 24 months after treatment. Planned recruitment and randomization of 100 patients was completed June 2015.
Detailed description
Occlusive disease of the femoro-popliteal arteries is associated with symptoms ranging from pain in the calf on exertion to pain at rest and ultimately ulceration and gangrene. Treatment options include a) conservative measures, with attention to medical risk factors, smoking cessation and exercise programmes, b) minimally invasive treatments such as angioplasty and c) surgical procedures such as femoro-popliteal bypass grafts.
Percutaneous transluminal angioplasty (PTA) has been widely used in the treatment of femoro-popliteal stenosis and occlusion for many years. However, the medium and long-term results have always been suboptimal due to a high rate of restenosis.
With restenosis rates of 70 % with PTA alone in long SFA lesions. Factors which contribute to poor results include the presence of occlusion rather than stenosis, the length of the lesion and the severity of run-off vessel disease.(1)
Stents are expandable metal mesh tubes which are widely used in the treatment of arterial disease in the coronary, renal and iliac arteries, where they have been shown to have superior patency to balloon angioplasty alone.
In the treatment of SFA lesions several early studies have investigated the patency of balloon expandable stents. These are stents with low flexibility and high risk of deformation in SFA. Medium and long-term results are not better than with PTA alone.(2)
Self expanding nitinol stents are stents generally with high flexibility and moderate to high radial force. Initial studies have shown promising results in the SFA.(3)
Early prospective randomised studies , the Sirocco I and II study show as low as 7 % restenosis rate at 6 months and 18% at 12 months self expanding nitinol stent.(4, 5) Later studies have focused on the issue of the correlation of stent fractures and low patency. These have shown that higher restenosis rates correlated to the length of the stented segment, number of stents and stent brand (6)
Up to now the most frequent use of stents in the SFA is "bailout" stenting. Investigated in a prospective randomised trial on patients with severe claudication or critical ischemia with long lesions (130 +- 60 mm) primary stenting in the SFA is showing superior results to PTA with bailout stenting on restenosis rate, ABI and walking distance.(7) There are for the moment two more trials investigating the results of direct stenting.
The FAST trial investigated claudicants with short lesions (4,5 cm); the stent arm used Luminexx stents versus PTA alone with no significant in difference in patency between both treatment arms after 12 months follow up.(8) The Resilient trial investigated patients with claudication and critical limb ischemia with 6,5 cm long lesions. The results are not published, but positive "pre hand" information has already come out. (9)
The most accepted treatment in claudicants is conservative best medical treatment with or without supervised walking training.(10) There is a trend to stent treatment in certain situations.
There are to the best of our knowledge no studies comparing direct stenting with conservative treatment in claudicants.
The aim of this study is to evaluate whether primary stenting with nitinol self expanding stent in patients suffering from stable claudication (Fontaine IIa and IIb) due to superficial femoral artery disease, results in improved patient outcomes, compared to conservative treatment alone as measured by improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys. Patients will be followed up 24 months after treatment.
A secondary objective is to study the impact of primary stenting versus conservative treatment on ABI and Walking Distance development during the 24 month follow up period. In addition, cost-parameters will be collected in each arm to allow for basic cost-effectiveness comparisons after 24 months.
12 month follow-up data have been published in Eur J Vasc Endovasc Surg 2017;53:686-694. All 24 month follow-up data have been collected, and a manuscript is in preparation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Stenting | Active comparator | Procedure: StentingActive treatment group |
| Conservative treatment | Placebo comparator | Other: Best medical treatmentBest medical treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Female patients with child bearing potential may not be pregnant at study entry and must utilize reliable birth control for the duration of their participation in the study.
- Patient suffering from stable claudication (Fontaine IIa and IIb).
- One de-novo or restenotic superficial femoral artery with the target treatment area not extending beyond approximately 3 cm above the patella at MRA.
- Patent popliteal artery on the index side, and runoff vessel situation at level six or better according to Rutherford classification prior to the day of the procedure. Target vessel diameter ≥ 4 mm at MRA.
Key exclusion criteria (10 listed)
- Recent hemorrhagic stroke (within past 3 months)
- Aneurysm in the SFA or popliteal artery
- Previously implanted stent(s) in the to be treated artery at the same site
- Poor aortoiliac or common femoral "inflow", which would be deemed inadequate to support a femoropopliteal bypass graft. However, intervention to restore adequate blood flow at least three months prior to the index procedure is allowed
- Significant vessel tortuosity or other parameters prohibiting access to the lesion or 90° tortuosity which would prevent delivery of the stent device
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 |
|---|---|---|
| StentingAlso: Endovascular treatment of claudicationThe stent should be deployed percutaneously, appropriate stent(s) size selected based upon the angiogram. The diameter must be 1-2 mm larger than the vessel. Length is chosen to cover lesion with one stent if possible. The choice of brand will be made through random selection among those offering possibility to cover the lesion with one stent. If more than one stent is required, overlap between 0.5 and 1 cm is acceptable. Postdilatation must be performed with a PTA balloon shorter than the length and less than the diameter of the stent. An angiogram should be made to compare the pre- and post-implant minimum lumen diameters. The non-diseased artery diameters shall be measured and residual % stenosis calculated. | Procedure or surgery | Stenting |
| Best medical treatmentAlso: Medical treatment of intermittent claudicationPatients randomised to conservative treatment will receive appropriate medication with target levels of cholesterol 4,5 mmol/l, LDL 2,5 mmol/l and blood pressure level of 130/80 mmHg in addition to instruction how to engage in an exercise program. Each patient will receive a 'step-meter' which has to be carried during all activity during the first month and then during one week before each follow up visit. Step-meter read-outs will be recorded during each follow up visit. Smokers will be actively advised to quit smoking. | Other | Conservative treatment |
Primary outcome
Improvement in Quality of Life scores
Time frame: 12 months
Improvement in Quality of Life scores at 12 months after treatment using SF-36 and EuroQol EQ-5D surveys
1 secondary outcome
Ankle/Brachial Index (ABI) and Walking Distance
Time frame: 24 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2017.
- Results publication: PubMed 28372983Lindgren H, Qvarfordt P, Akesson M, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Intermittent Claudication Improves Health Related Quality of Life, ABI and Walking Distance: 12 Month Results of a Controlled Randomised Multicentre Trial. Eur J Vasc Endovasc Surg. 2017 May;53(5):686-694. doi: 10.1016/j.ejvs.2017.01.026. Epub 2017 Mar 31.
- Derived from this study: PubMed 29520431Lindgren HIV, Qvarfordt P, Bergman S, Gottsater A; Swedish Endovascular Claudication Stenting Trialists. Primary Stenting of the Superficial Femoral Artery in Patients with Intermittent Claudication Has Durable Effects on Health-Related Quality of Life at 24 Months: Results of a Randomized Controlled Trial. Cardiovasc Intervent Radiol. 2018 Jun;41(6):872-881. doi: 10.1007/s00270-018-1925-0. Epub 2018 Mar 8.
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.
Hans Lindgren, MD principal investigator
Dept of Radiology, Helsingborg Hospital, Helsingborg, Sweden
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stenting and Best medical treatment in people with Stable Claudication (Fontaine IIa and IIb) and Superficial Femoral Artery Disease, run by Lund University at 2 sites in Sweden.
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 10 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: finished, as of the sponsor's last update on 23 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. 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. Some participants in this study may receive a placebo. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Improvement in Quality of Life scores (time frame: 12 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 NCT01230229, which also lists 2 linked publications.
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 23 Aug 2017.