Peripheral Arterial DiseaseSTRONGNCT03227822
Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease
A study testing Short spot stenting and Long lesion stenting in people with Peripheral Arterial Disease, run by Catharina Ziekenhuis Eindhoven.
Trial summary
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Short spot stenting and Long lesion stenting
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- No sites listed yet
- Study dates
- Jul 2013to 1 Feb 2015
- 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
- PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
- Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
- Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
- Unilateral occlusive disease
- Age ≥ 18
Who cannot join
- Patients with PAOD Rutherford category 5 and 6
- Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
- Bilateral lesions with treatment indication
- Contra-indication for anticoagulant therapy
- Renal insufficiency (MDRD < 50 ml/min)
- Life expectancy < 6 months
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- Known contrast allergy
- Pregnancy
- Unable to complete a questionnaire in the home language
About this study
Official title: Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Short spot stenting, Long lesion stenting
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Short spot stentingProcedure or surgery
Long lesion stentingProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Short spot stenting | Experimental | Short spot stenting Receives: Procedure: Short spot stenting |
| Long lesion stenting | Experimental | Long lesion stenting Receives: Procedure: Long lesion stenting |
What is being measured
The primary outcome is the main question the study is designed to answer.
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2017
- Study startJul 2013
- Primary completion1 Feb 2015
- Study completion1 Feb 2015
Why it stopped: Unable to include the number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Catharina Ziekenhuis Eindhoven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc van Sambeek, Catharina Ziekenhuis Eindhoven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03227822
- Sponsor's protocol ID
- STRONG SFA study
- Other IDs
- NL43610.060.13
- Acronym
- STRONG
- Status last verified
- Oct 2018
- First submitted
- 21 Jul 2017
- Last updated
- 9 Oct 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Spot Versus Long Lesion Stenting as Best Treatment for Extensive Occlusive SFA Disease; a Pilot Study
- ClinicalTrials.gov ID
- NCT03227822
- Acronym / sponsor ID
- STRONG / STRONG SFA study
- Conditions
- Peripheral Arterial Disease
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to include the number of patients
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Catharina Ziekenhuis EindhovenUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- 1 Feb 2015 (actual)
- Study completion
- 1 Feb 2015 (actual)
- First posted
- 24 Jul 2017 (actual)
- 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.
Since the length of lesion seems to be negatively associated with stent patency due to restenosis, it is thought that the efficacy of treatment in patients with multiple (> 1) short (focal; > 1 and < 5 cm) SFA lesions can be improved by spot stenting as compared to the use of one long stent. This study proposes to evaluate the endovascular treatment for patients with SFA lesions by comparing two strategies for patients with extensive occlusive SFA disease; 1) short spot (SS) stenting or 2) long lesion (LL) stenting.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Short spot stenting | Experimental | Procedure: Short spot stentingShort spot stenting |
| Long lesion stenting | Experimental | Procedure: Long lesion stentingLong lesion stenting |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- PAOD (ABI <0.90 and/or a decline of >0.15 after exercise test), Rutherford category 2, 3 or 4
- Multiple (>1) short (focal; >1 and < 5 cm) significant stenoses (≥ 50%) and/or occlusions in the superficial femoral artery
- Eligible for endovascular treatment via short spot stenting and via long lesion stenting according to international guidelines
- Unilateral occlusive disease
- Age ≥ 18
Key exclusion criteria (9 listed)
- Patients with PAOD Rutherford category 5 and 6
- Impaired inflow due to significant lesions in the arteries proximal to the SFA intended to treat
- Bilateral lesions with treatment indication
- Contra-indication for anticoagulant therapy
- Renal insufficiency (MDRD < 50 ml/min)
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 |
|---|---|---|
| Short spot stenting | Procedure or surgery | Short spot stenting |
| Long lesion stenting | Procedure or surgery | Long lesion stenting |
Primary outcome
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention
Time frame: 1 year
Results and safety
The study was stopped early (reason given: Unable to include the number of patients). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Short spot stenting and Long lesion stenting in people with Peripheral Arterial Disease, run by Catharina Ziekenhuis Eindhoven.
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 5 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 9 Oct 2018. 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?
The study was stopped early (reason given: Unable to include the number of patients). 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?
absence of binary restenosis (≥ 50% re-obstruction) of the target lesion without interval clinically driven reintervention (time frame: 1 year). 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 9 Oct 2018.