Peripheral Arterial Occlusive DiseaseREVASNCT00566436
Remote Endarterectomy Versus Suprageniculate Femoropopliteal Bypass
A study testing Remote endarterectomy of the superficial femoral artery and Suprageniculate femoropopliteal bypass in people with Peripheral Arterial Occlusive Disease and Atherosclerosis, run by St. Antonius Hospital at 4 sites in Netherlands.
Trial summary
The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Occlusive Disease, Atherosclerosis
- What is being tested?
- Remote endarterectomy of the superficial femoral artery and Suprageniculate femoropopliteal bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 4 sitesNetherlands
- Study dates
- Oct 2004to Mar 2012
- 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 presenting with Fontaine IIB, III, IV ischemia
- Long (>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
- Atherosclerotic disease
Who cannot join
- Previous operations on the superficial femoral artery
- Radiation therapy groin/leg region
- Diameter superficial femoral artery < 4 mm
- Contrast allergy
Trial locations and contacts
4 sites in 1 country.
Netherlands4 sites
Amphia Hospital
Breda, North Brabant, 4818CK
Albert Schweitzer Ziekenhuis
Dordrecht, South Holland, 3318AT
St Antonius Hospital
Nieuwegein, Utrecht, 3435CM
UMC Utrecht
Utrecht, Utrecht, 3584CX
About this study
Official title: The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
The objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.
Read the detailed description
Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.
- Being tested
- Remote endarterectomy of the superficial femoral artery, Suprageniculate femoropopliteal bypass
- Keywords
- Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency
- Medical subject headings
- Peripheral Arterial Occlusive Disease 1, Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Remote endarterectomy of the superficial femoral arteryProcedure or surgery
Also called Remote superficial artery endarterectomy, Distal cutting endarterectomy
Exposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch.
Suprageniculate femoropopliteal bypassProcedure or surgery
Also called Above knee bypass, Femoropopliteal bypass
Groin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping)
| Study group | Role | What they receive |
|---|---|---|
| REA | Active comparator | Patients presenting with a long occlusion of the superficial femoral artery enrolled in REA arm will undergo remote endarterectomy of the occluded superficial femoral artery Receives: Procedure: Remote endarterectomy of the superficial femoral artery |
| Bypass | Active comparator | Patients presenting with a long occlusion of the superficial femoral artery enrolled in Bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery Receives: Procedure: Suprageniculate femoropopliteal bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
Measured: 5 year
Secondary outcomes (2)
(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
Measured: 5 year
major amputation of the ipsilateral leg
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2007 (estimated)
- Study startOct 2004
- Study completionMar 2012 (estimated)
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 Peripheral Arterial Occlusive 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- UMC Utrecht, Albert Schweitzer Hospital, Netherlands, Amphia Hospital
- Investigators
- Suzanne S Gisbertz, MD, Principal investigator, St. Antonius HospitalJean Paul PM de Vries, MD, PhD, Principal investigator, St. Antonius HospitalFrans L Moll, MD, PhD, Principal investigator, UMC Utrecht
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00566436
- Sponsor's protocol ID
- C-04.04
- Other IDs
- P.04.1298L
- Acronym
- REVAS
- Status last verified
- Nov 2007
- First submitted
- 29 Nov 2007
- Last updated
- 3 Dec 2007
- Results posted
- No
- Data monitoring committee
- No
Publications
Smeets L, Ho GH, Hagenaars T, van den Berg JC, Teijink JA, Moll FL. Remote endarterectomy: first choice in surgical treatment of long segmental SFA occlusive disease? Eur J Vasc Endovasc Surg. 2003 Jun;25(6):583-9. doi: 10.1053/ejvs.2002.1921.
PubMed 12787704Gisbertz SS, Ramzan M, Tutein Nolthenius RP, van der Laan L, Overtoom TT, Moll FL, de Vries JP. Short-term results of a randomized trial comparing remote endarterectomy and supragenicular bypass surgery for long occlusions of the superficial femoral artery [the REVAS trial]. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):68-76. doi: 10.1016/j.ejvs.2008.09.014. Epub 2008 Nov 5.
PubMed 18990592
Study at a glance
From the registry record, last updated by the sponsor on 3 Dec 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surgical Treatment of Long Occlusions of the Superficial Femoral Artery: Initial Success and Long Term Results of Remote Endarterectomy Versus Suprageniculate Bypass Surgery
- ClinicalTrials.gov ID
- NCT00566436
- Acronym / sponsor ID
- REVAS / C-04.04
- Keywords
- Peripheral Arterial Occlusive Disease, Superficial Femoral Artery, Remote Endarterectomy, Suprageniculate Bypass Surgery, Blood Vessel Prosthesis Implantation, Vascular Patency
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 126 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Collaborators
- UMC Utrecht, Albert Schweitzer Hospital, Netherlands, Amphia Hospital
- Study start
- Oct 2004
- Study completion
- Mar 2012 (estimated)
- First posted
- 3 Dec 2007 (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 objective of this study is to compare remote superficial femoral artery endarterectomy with suprageniculate bypass surgery in the treatment of long occlusions of the superficial femoral artery. The study hypothesis is that patency rates are comparable and therefore the minimal invasive remote superficial femoral artery endarterectomy can be considered in patients presenting with a long occlusion of the superficial femoral artery.
Detailed description
Different strategies exist in the treatment of chronic long occlusions of the superficial femoral artery and yet we still suffer a significant percentage of restenosis, re-occlusions and even major amputations, reason for continuous development of new techniques. One such technique is the recently developed minimal invasive remote endarterectomy, which shows promising patency rates and possibly less complications with earlier recovery. A more experienced and the most implemented technique is the suprageniculate femoropopliteal bypass graft, which, when using the saphenous vein, has proved durable. A randomized trial comparing both modalities was lacking so far, what makes the objective of this study a comparison of patency rates between those 2 techniques in a randomized fashion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REA | Active comparator | Procedure: Remote endarterectomy of the superficial femoral arteryPatients presenting with a long occlusion of the superficial femoral artery enrolled in REA arm will undergo remote endarterectomy of the occluded superficial femoral artery |
| Bypass | Active comparator | Procedure: Suprageniculate femoropopliteal bypassPatients presenting with a long occlusion of the superficial femoral artery enrolled in Bypass arm will undergo suprageniculate femoropopliteal bypass surgery to bypass the occluded superficial femoral artery |
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 presenting with Fontaine IIB, III, IV ischemia
- Long (>10 cm) occlusion of the superficial femoral artery, with patent popliteal artery and at least 1 patent crural vessel
- Atherosclerotic disease
Key exclusion criteria (4 listed)
- Previous operations on the superficial femoral artery
- Radiation therapy groin/leg region
- Diameter superficial femoral artery < 4 mm
- Contrast allergy
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 |
|---|---|---|
| Remote endarterectomy of the superficial femoral arteryAlso: Remote superficial artery endarterectomy, Distal cutting endarterectomyExposure of the common femoral, superficial femoral and profunda femoral artery through a single groin incision. Arteriotomy in the proximal SFA followed by dissection of the intima core beyond the occluded segment using the Vollmar ringstripper. The ringstripper is exchanged for a Mollring cutter all under fluoroscopic guidance. With the Mollring Cutter transection of intima core is carried out, remote from the site of entry. After removal of the intima core the transection zone is secured with an aSpire stent after balloon angioplasty. A completion arteriography will verify a patent artery, and embolectomy can be performed when necessary. As indicated a common femoral artery and profundaplasty can be performed and the arteriotomy may be closed with or without patch. | Procedure or surgery | REA |
| Suprageniculate femoropopliteal bypassAlso: Above knee bypass, Femoropopliteal bypassGroin and suprageniculate incision, venous (Saphenous vein) or PTFE graft with end to side anastomoses. If the saphenous vein is truly applicable for grafting will ultimately be an intra-operative decision (despite pre-operative venous mapping) | Procedure or surgery | Bypass |
Primary outcome
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass
Time frame: 5 year
2 secondary outcomes
(a)symptomatic (re)stenosis of the superficial femoral artery or bypass for which a re-intervention was carried out
Time frame: 5 year
major amputation of the ipsilateral leg
Time frame: 5 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2007.
- Background: PubMed 12787704Smeets L, Ho GH, Hagenaars T, van den Berg JC, Teijink JA, Moll FL. Remote endarterectomy: first choice in surgical treatment of long segmental SFA occlusive disease? Eur J Vasc Endovasc Surg. 2003 Jun;25(6):583-9. doi: 10.1053/ejvs.2002.1921.
- Derived from this study: PubMed 18990592Gisbertz SS, Ramzan M, Tutein Nolthenius RP, van der Laan L, Overtoom TT, Moll FL, de Vries JP. Short-term results of a randomized trial comparing remote endarterectomy and supragenicular bypass surgery for long occlusions of the superficial femoral artery [the REVAS trial]. Eur J Vasc Endovasc Surg. 2009 Jan;37(1):68-76. doi: 10.1016/j.ejvs.2008.09.014. Epub 2008 Nov 5.
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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.
Suzanne S Gisbertz, MD principal investigator
St. Antonius Hospital
Jean Paul PM de Vries, MD, PhD principal investigator
St. Antonius Hospital
Frans L Moll, MD, PhD principal investigator
UMC Utrecht
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Remote endarterectomy of the superficial femoral artery and Suprageniculate femoropopliteal bypass in people with Peripheral Arterial Occlusive Disease and Atherosclerosis, run by St. Antonius Hospital at 4 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 3 inclusion and 4 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 3 Dec 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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?
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?
(re-)occlusion of the endarterectomized superficial femoral artery or suprageniculate femoropopliteal bypass (time frame: 5 year). 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 NCT00566436, 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 3 Dec 2007.