Cardiovascular DiseasesSuperBNCT01220245
SuperB Trial: SUrgical Versus PERcutaneous Bypass
A study testing Heparin-bonded ePTFE endoluminal fem-pop bypass and Surgical femoro-popliteal bypass. in people with Cardiovascular Diseases, run by Rijnstate Hospital at 6 sites in Netherlands.
Trial summary
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Heparin-bonded ePTFE endoluminal fem-pop bypass and Surgical femoro-popliteal bypass.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 129 participants
- Where
- 6 sitesNetherlands
- Study dates
- Oct 2010to Aug 2020
- 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 over 18 years
- Informed consent
- Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length
- Patent popliteal artery at the upper margin of the patella to the trifurcation
- Diameter native SFA and popliteal artery are 5.0-7.5 mm
- Indication for surgical bypass
- Distal run-off at least one crural artery without significant stenosis
- Ankle-brachial index (ABI) at rest < 0.8 in the study limb prior to procedure
Who cannot join
- Patient unsuitable for administration of contrast agent
- Pregnancy
- Dementia or altered mental status that would prohibit giving conscious informed consent
- Need for adjunctive major surgical or vascular procedures within one month
- Untreated flow-limiting aortoiliac occlusive disease
- Perioperative unsuccessful ipsilateral percutaneous vascular procedure to treat inflow disease just prior to enrollment
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- Femoral or popliteal aneurysm of target vessel
- Non-arthrotic disease resulting in occlusion (e.g. embolism, Buerger's disease, vasculitis)
- Severe medical comorbidities (untreated CAD/CHF, severe COPD, metastatic malignancies, dementia etc.) or other medical condition that would preclude compliance with study protocol
- Major distal amputation (above the transmetatarsal) in the study limb
- Any previously known coagulation disorder, including hypercoagulability
- Contraindication to anticoagulation or antiplatelet therapy
- Known allergies to stent/stent-graft components
- History of prior life-threatening reaction to contrast agent
- Patients with known hypersensitivity to heparin, including those patients who have had a previous incidence of heparin-induced thrombocytopenia (HIT) type II
- Planned surgical procedure or major amputation to occur after enrollment of the patient
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Netherlands6 sites
Rijnstate Hospital
Arnhem, Gelderland
Slingeland Hospital
Doetinchem, Gelderland
Nij Smellinghe Hospital
Drachten, Provincie Friesland
University Medical Centre Groningen
Groningen
Antonius Hospital
Sneek, Provincie Friesland
Isala klinieken
Zwolle, Overijssel
About this study
Official title: Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.
- Conditions
- Cardiovascular Diseases
- Being tested
- Heparin-bonded ePTFE endoluminal fem-pop bypass, Surgical femoro-popliteal bypass.
- Keywords
- endoluminal, surgical, bypass, patency, quality of life, multicentre, RCT, superficial femoral artery, vascular patency
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heparin-bonded ePTFE endoluminal fem-pop bypassProcedure or surgery
Heparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass
Surgical femoro-popliteal bypass.Procedure or surgery
Surgical femoro-popliteal bypass.
| Study group | Role | What they receive |
|---|---|---|
| Heparin-bonded endoluminal fempop bypass | Experimental | Heparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass Receives: Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypass |
| Surgical femoro-popliteal bypass | Active comparator | Surgical femoro-popliteal bypass. Receives: Procedure: Surgical femoro-popliteal bypass. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary (and -assisted) patency
Measured: 5 years
Quality of life
Measured: 5 years
Secondary outcomes (5)
Secondary patency
Measured: 5 years
Complications
Measured: 5 years
Clinical improvement
Measured: 5 years
Re-intervention
Measured: 5 years
Target lesion revascularisation
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionAug 2020
- Study completionAug 2020
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 Cardiovascular DiseasesStudies 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
- 129 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rijnstate Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michel Reijnen, Rijnstate Hospital
- Investigators
- MMJP Reijnen, MD, PhD, Principal investigator, Rijnstate Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01220245
- Sponsor's protocol ID
- 721-070910
- Acronym
- SuperB
- Status last verified
- Jan 2021
- First submitted
- 11 Oct 2010
- Last updated
- 25 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
van Walraven LA, Velandia-Sanchez A, Iqbal K, Zeebregts CJ, Holewijn S, Reijnen MMPJ. Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass. J Endovasc Ther. 2026 Feb;33(1):220-226. doi: 10.1177/15266028241245602. Epub 2024 Apr 9.
PubMed 38590283Lensvelt MM, Holewijn S, Fritschy WM, Wikkeling OR, van Walraven LA, Wallis de Vries BM, Zeebregts CJ, Reijnen MM. SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial. Trials. 2011 Jul 18;12:178. doi: 10.1186/1745-6215-12-178.
PubMed 21767371
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heparin-bonded Endoluminal Versus Surgical Femoropopliteal Bypass; a Multicentre Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01220245
- Acronym / sponsor ID
- SuperB / 721-070910
- Conditions
- Cardiovascular Diseases
- Keywords
- endoluminal, surgical, bypass, patency, quality of life, multicentre, RCT, superficial femoral artery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 129 participants (actual)
- Lead sponsor
- Rijnstate HospitalUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Aug 2020 (actual)
- Study completion
- Aug 2020 (actual)
- First posted
- 13 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.
In this multicentre Randomized Clinical Trial, the heparin-bonded endoluminal bypass will be compared to the surgical venous femoro-popliteal bypass, based on the non-inferiority principle for the patency. Besides equal patency, an improved quality of life is expected. Recruitment will take the first two years and patients will be followed during five years. Patients with an indication for surgical bypass, classified category 3-6 with a >50% stenosis or occlusion of the SFA over >/=10 cm in length will be included. At least one crural artery should be patent without significant lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Heparin-bonded endoluminal fempop bypass | Experimental | Procedure: Heparin-bonded ePTFE endoluminal fem-pop bypassHeparin-bonded ePTFE endoluminal femoro-popliteal bypass versus surgical femoro-popliteal bypass |
| Surgical femoro-popliteal bypass | Active comparator | Procedure: Surgical femoro-popliteal bypass.Surgical femoro-popliteal bypass. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age over 18 years
- Informed consent
- Novo stenosis, restenosis >50% or occlusion of the native SFA, all > 10cm in length
- Patent popliteal artery at the upper margin of the patella to the trifurcation
- Diameter native SFA and popliteal artery are 5.0-7.5 mm
Key exclusion criteria (16 listed)
- Patient unsuitable for administration of contrast agent
- Pregnancy
- Dementia or altered mental status that would prohibit giving conscious informed consent
- Need for adjunctive major surgical or vascular procedures within one month
- Untreated flow-limiting aortoiliac occlusive disease
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 |
|---|---|---|
| Heparin-bonded ePTFE endoluminal fem-pop bypassHeparin-bonded ePTFE endoluminal femoropopliteal bypass versus surgical femoropopliteal bypass | Procedure or surgery | Heparin-bonded endoluminal fempop bypass |
| Surgical femoro-popliteal bypass.Surgical femoro-popliteal bypass. | Procedure or surgery | Surgical femoro-popliteal bypass |
Primary outcome
Primary (and -assisted) patency
Time frame: 5 years
Quality of life
Time frame: 5 years
5 secondary outcomes
Secondary patency
Time frame: 5 years
Complications
Time frame: 5 years
Clinical improvement
Time frame: 5 years
Re-intervention
Time frame: 5 years
Target lesion revascularisation
Time frame: 5 years
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 25 Jan 2021.
- Derived from this study: PubMed 38590283van Walraven LA, Velandia-Sanchez A, Iqbal K, Zeebregts CJ, Holewijn S, Reijnen MMPJ. Impact on Hospital Resource Utilization of Endoluminal Bypass Using the Viabahn Endoprosthesis with Heparin Bioactive Surface Compared With Surgical Femoropopliteal Bypass. J Endovasc Ther. 2026 Feb;33(1):220-226. doi: 10.1177/15266028241245602. Epub 2024 Apr 9.
- Derived from this study: PubMed 21767371Lensvelt MM, Holewijn S, Fritschy WM, Wikkeling OR, van Walraven LA, Wallis de Vries BM, Zeebregts CJ, Reijnen MM. SUrgical versus PERcutaneous Bypass: SUPERB-trial; Heparin-bonded endoluminal versus surgical femoro-popliteal bypass: study protocol for a randomized controlled trial. Trials. 2011 Jul 18;12:178. doi: 10.1186/1745-6215-12-178.
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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.
MMJP Reijnen, MD, PhD principal investigator
Rijnstate Hospital
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Heparin-bonded ePTFE endoluminal fem-pop bypass and Surgical femoro-popliteal bypass. in people with Cardiovascular Diseases, run by Rijnstate Hospital at 6 sites in Netherlands.
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 8 inclusion and 16 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 25 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Netherlands. 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 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?
Primary (and -assisted) patency (time frame: 5 years). The study lists 2 primary outcomes in all. 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 NCT01220245, 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 25 Jan 2021.