Aortobifemoral BypassNLASTNCT01793662
Norwegian Laparoscopic Aortic Surgery Trial
A study testing Laparoscopic aortobifemoral bypass in people with Aortobifemoral Bypass and Aortoiliac Occlusive Disease, run by Oslo University Hospital at 1 site in Norway.
Trial summary
Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Aortobifemoral Bypass, Aortoiliac Occlusive Disease, TASC Type D Lesions
- What is being tested?
- Laparoscopic aortobifemoral bypass
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 126 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2013to 30 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Aortoiliac occlusive disease (TASC Type D lesions)
Who cannot join
- Active cancer disease
- Acute critical limb ischemia
- Prior major abdominal surgery
- Heart failure (Ejection fraction <40%
Trial locations and contacts
1 site in 1 country.
About this study
Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.
However, no randomized control trial has yet been published to compare the two procedures.
In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.
Read the detailed description
The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.
Secondary endpoints are as follows,
- health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.
- perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes
- perioperative inflammatory response
- cost-utility analysis
- cost differences
- Conditions
- Aortobifemoral Bypass, Aortoiliac Occlusive Disease, TASC Type D Lesions, Laparoscopic Versus Open Bifurcation Graft
- Being tested
- Laparoscopic aortobifemoral bypass
- Keywords
- Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Laparoscopic aortobifemoral bypassProcedure or surgery
Also called Laparoscopic aortic surgery, laparoscope
Totally laparoscopic aortobifemoral bypass shall be performed and the patients in this intervention arm shall be compared with the control arm randomized for open aortobifemoral bypass operation.
| Study group | Role | What they receive |
|---|---|---|
| Open aortobifemoral bypass | Active comparator | Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation. Receives: Procedure: Laparoscopic aortobifemoral bypass |
| Laparoscopic aortobifemoral bypass | Experimental | Patients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation. Receives: Procedure: Laparoscopic aortobifemoral bypass |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative complications
Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.
Measured: 2.9 years
Secondary outcomes (1)
health related quality of life
The bodily pain domain of the SF36-v2 at 3 months postoperatively shall be used to assess the patients in the two groups of NLAST study. Besides EQ-5D-5L shall be used pre and post operatively for QoL evaluation.
Measured: 3 months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completion30 Dec 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Aortobifemoral BypassStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Sajid Hussain Kazmi, Oslo University Hospital
- Investigators
- Syed Sajid Hussain Kazmi, MD, PhD, Principal investigator, Department of vascular surgery, Oslo University Hospital, Oslo, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01793662
- Sponsor's protocol ID
- NLAST2012
- Acronym
- NLAST
- Status last verified
- Jun 2025
- First submitted
- 14 Feb 2013
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Kazmi SSH, Sahba M, Pettersen EM, Krog AH, Fagerland MW, Sundhagen JO. Editor's Choice - Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Eur J Vasc Endovasc Surg. 2026 Mar;71(3):374-383. doi: 10.1016/j.ejvs.2025.09.046. Epub 2025 Nov 7.
PubMed 41207501
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Laparoscopic Aortic Surgery Trial
- ClinicalTrials.gov ID
- NCT01793662
- Acronym / sponsor ID
- NLAST / NLAST2012
- Conditions
- Aortobifemoral Bypass, Aortoiliac Occlusive Disease, TASC Type D Lesions, Laparoscopic Versus Open Bifurcation Graft
- Keywords
- Aortobifemoral bypass, Laparoscopic aortic surgery, Aortoiliac occlusive disease, TASC Type D Lesions, Open aortic surgery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- 30 Dec 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 15 Feb 2013 (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.
Patients with severe atherosclerotic occlusive disease can be operated on with an aortobifemoral bypass(ABFB)through a median laparotomy. Since 1993, this operation has also been performed laparoscopically. The laparoscopic ABFB operation claims to be minimally invasive as compared to the open ABFB. The cohort studies published so far have shown that although a longer operation time with the laparoscopic procedure as compared to the open surgery, the patients have a shorter hospital stay, lesser perioperative bleeding, fewer systemic complications, and earlier convalescence.
However, no randomized control trial has yet been published to compare the two procedures.
In the NLAST-study, which is a multicenter randomized control trial, the patients with TASC type D atherosclerotic lesions shall be randomized to either totally laparoscopic aortobifemoral bypass operation (LABFB)or an open ABFB operation.
Detailed description
The primary endpoint of the study is post-operative complications defined as systemic and local complications, including vascular complications e.g., graft infection, thrombosis, etc.
Secondary endpoints are as follows,
- health-related quality of life, examined and evaluated with the help of pre and post-operative surveys performed with the help of SF36v2 questionnaire and EQ5D5L.
- perioperative stress response (during operation) measured/analyzed with the help of stress hormones changes
- perioperative inflammatory response
- cost-utility analysis
- cost differences
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Open aortobifemoral bypass | Active comparator | Procedure: Laparoscopic aortobifemoral bypassPatients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation. |
| Laparoscopic aortobifemoral bypass | Experimental | Procedure: Laparoscopic aortobifemoral bypassPatients with aortoiliac occlusive disease (only, TASC Type D lesions) shall be randomized to either laparoscopic aortobifemoral bypass or open aortobifemoral bypass operation. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Aortoiliac occlusive disease (TASC Type D lesions)
Key exclusion criteria (4 listed)
- Active cancer disease
- Acute critical limb ischemia
- Prior major abdominal surgery
- Heart failure (Ejection fraction <40%
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 |
|---|---|---|
| Laparoscopic aortobifemoral bypassAlso: Laparoscopic aortic surgery, laparoscopeTotally laparoscopic aortobifemoral bypass shall be performed and the patients in this intervention arm shall be compared with the control arm randomized for open aortobifemoral bypass operation. | Procedure or surgery | Laparoscopic aortobifemoral bypass, Open aortobifemoral bypass |
Primary outcome
Postoperative complications
Time frame: 2.9 years
Postoperative complications during a mean follow-up period of 2.9 years are the primary outcome measure of NLAST.
1 secondary outcome
health related quality of life
Time frame: 3 months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 41207501Kazmi SSH, Sahba M, Pettersen EM, Krog AH, Fagerland MW, Sundhagen JO. Editor's Choice - Norwegian Randomised Trial of Laparoscopic versus Open Aortobifemoral Bypass: The Norwegian Laparoscopic Aortic Surgery Trial (NLAST). Eur J Vasc Endovasc Surg. 2026 Mar;71(3):374-383. doi: 10.1016/j.ejvs.2025.09.046. Epub 2025 Nov 7.
- Individual participant dataSharing planned: Undecided
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.
Syed Sajid Hussain Kazmi, MD, PhD principal investigator
Department of vascular surgery, Oslo University Hospital, Oslo, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Laparoscopic aortobifemoral bypass in people with Aortobifemoral Bypass and Aortoiliac Occlusive Disease, run by Oslo University Hospital at 1 site in Norway.
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 1 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: under way, not looking for participants, as of the sponsor's last update on 3 Jul 2025. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Postoperative complications (time frame: 2.9 years). 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 NCT01793662, which also lists 1 linked publication.
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 Jul 2025.