Peripheral Arterial DiseaseSWEDEPADNCT02051088
Swedish Drug-elution Trial in Peripheral Arterial Disease
A study testing Revascularization with drug-eluting technology, Revascularization without drug-eluting technology and drug-coated balloons and/or drug-eluting stents in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Sahlgrenska University Hospital at 1 site in Sweden.
Trial summary
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Peripheral Arterial Disease, Critical Limb Ischemia, Intermittent Claudication
- What is being tested?
- Revascularization with drug-eluting technology, Revascularization without drug-eluting technology and drug-coated balloons and/or drug-eluting stents
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,556 participants
- Where
- 1 siteSweden
- Study dates
- Nov 2014to 31 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All adults > 18 years old willing to be randomized
- Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications
Who cannot join
- Acute thromboembolic disease in the leg
- Infrainguinal aneurysmal disease
- Previous participation in the study or in other randomised interventional study of infrainguinal lesions
- Patients without a Swedish personal identification number
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).
In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.
In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
- Being tested
- Revascularization with drug-eluting technology, Revascularization without drug-eluting technology, drug-coated balloons and/or drug-eluting stents
- Keywords
- Critical limb ischemia, Intermittent claudication, endovascular treatment, drug-elution
- Medical subject headings
- Peripheral Arterial Disease, Chronic Limb-Threatening Ischemia, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Revascularization with drug-eluting technologyProcedure or surgery
Endovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents).
Revascularization without drug-eluting technologyProcedure or surgery
Endovascular intervention without using drug-eluting balloons or stents
drug-coated balloons and/or drug-eluting stentsDevice
| Study group | Role | What they receive |
|---|---|---|
| Revascularization with drug eluting technology | Experimental | Revascularization with drug eluting technology Receives: Procedure: Revascularization with drug-eluting technology; Device: drug-coated balloons and/or drug-eluting stents |
| Revascularization without drug elution | Active comparator | Revascularization without drug elution technology Receives: Procedure: Revascularization without drug-eluting technology |
What is being measured
The primary outcome is the main question the study is designed to answer.
Amputation rate (SWEDEPAD 1)
Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year.
Measured: Assessed when all patients have been followed for at least one year
Health-related quality of life (SWEDEPAD 2)
Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD.
Measured: Assessed one year after randomization
Secondary outcomes (9)
Amputation-free survival
Measured: Assessed when all participants have been followed for at least one, three and five years.
Survival
Measured: Assessed when all participants have been followed for at least one, three and five years.
Target lesion revascularization (TLR)
Need for re-intervention during follow-up
Measured: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Time to target lesion revascularization
Measured: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Patency
Patency, defined as freedom from binary restenosis, a reduction in lumen diameter ≥50% in patients assessed with duplex ultrasound after one month and after one year (only certain centres).
Measured: Assessed after 1 month and 1 year
Improvement in clinical symptoms, assessed with the Rutherford classification
Particularly changes from Rutherford categories 4, 5 and 6 to lower categories will analysed (SWEDEPAD 1)
Particularly changes from Rutherford categories 2 and 3 to other categories will analysed (SWEDEPAD 2)
Measured: Assessed after one month and one year
Health-related quality of life (SWEDEPAD 1)
Health-related quality of life, assessed with the disease-specific instrument VascuQoL-6
Measured: Assessed after one year following randomisation
Amputation rate (SWEDEPAD 2)
Measured: Assessed one year after the intervention and when all participants have been followed for one, three and five years
Health-economic assessment
Assessment of cost-effectiveness and clinical utility (only certain centres).
Measured: Assessed one year after the intervention and when all participants have been followed for one, three and five years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2014 (estimated)
- Study startNov 2014
- Primary completion30 Apr 2025
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- More trials run by Sahlgrenska 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 3,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sahlgrenska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation, Uppsala University, The Swedish National Registry for Vascular Surgery
- Responsible party
- Principal investigator, Mårten Falkenberg, Sahlgrenska University Hospital
- Investigators
- Mårten Falkenberg, MD, PhD, Principal investigator, Department of Radiology, Sahlgrenska University HospitalJoakim Nordanstig, MD, Study chair, Department of Vascular Surgery, Sahlgrenska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02051088
- Sponsor's protocol ID
- SWEDEPAD
- Acronym
- SWEDEPAD
- Status last verified
- Jul 2025
- First submitted
- 27 Jan 2014
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sellgren F, Falkenberg M, Andersson M, Andersson M, Le Corvec T, Delle M, Engstrom J, Fransson T, Hilbertson A, Horer TM, Jacobsson E, James S, Kragsterman B, Lindback J, Lindgren H, Mellander S, Olin R, Sigvant B, Skoog P, Smedberg C, Starck J, Tegler G, Thorbjornsen K, Truedson M, Tornqvist P, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J. Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial. Circ Cardiovasc Interv. 2026 Sep 24:e016977. doi: 10.1161/CIRCINTERVENTIONS.126.016977. Online ahead of print.
PubMed 42779544Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
PubMed 42573020Le Corvec T, Falkenberg M, Gillgren P, James S, Lindback J, Lindgren H, Sellgren F, Skoog P, Wahlgren CM, Nordanstig J; SWEDEPAD Steering Committee. Impact of Paclitaxel Coated Devices on Limb Salvage and Target Vessel Revascularisation Rates following Isolated Femoropopliteal or Infrapopliteal Endovascular Revascularisation for Chronic Limb Threatening Ischaemia: Insights from the SWEDEPAD 1 Trial. Eur J Vasc Endovasc Surg. 2026 Jul 15:S1078-5884(26)00701-X. doi: 10.1016/j.ejvs.2026.07.023. Online ahead of print.
PubMed 42456888Falkenberg M, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1103-1114. doi: 10.1016/S0140-6736(25)01585-5. Epub 2025 Aug 31.
PubMed 40902617Nordanstig J, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1115-1127. doi: 10.1016/S0140-6736(25)01584-3. Epub 2025 Aug 31.
PubMed 40902614Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engstrom J, Fransson T, Hamoud M, Hilbertson A, Johansson P, Karlsson L, Kragsterman B, Lindgren H, Ludwigs K, Mellander S, Nyman N, Renlund H, Sigvant B, Skoog P, Starck J, Tegler G, Toivola A, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9.
PubMed 33296560
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Swedish Drug-elution Trial in Peripheral Arterial Disease - a Multicenter, Prospective Randomized Controlled Clinical Trial Based on the Swedish Vascular Registry (SWEDVASC) Platform
- ClinicalTrials.gov ID
- NCT02051088
- Acronym / sponsor ID
- SWEDEPAD / SWEDEPAD
- Keywords
- Critical limb ischemia, Intermittent claudication, endovascular treatment, drug-elution
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,556 participants (actual)
- Lead sponsor
- Sahlgrenska University HospitalUniversity, hospital or other
- Collaborators
- The Swedish Research Council, Swedish Heart Lung Foundation, Uppsala University, The Swedish National Registry for Vascular Surgery
- Study start
- Nov 2014 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 31 Jan 2014 (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.
Peripheral arterial disease (PAD) causes reduced blood flow to the lower limb(s) due to stenosis or occlusion in the supplying arteries. Symptoms of PAD range from ischemic rest pain and/or ischemic ulcers/gangrene (critical limb ischemia), putting the extremity at risk of amputation, to exercise-induced pain (intermittent claudication), limiting the patients daily activities. Invasive treatments are often indicated to prevent amputations and to alleviate symptoms. More than two thirds of these procedures are presently performed with endovascular techniques (i.e. percutaneous transluminal angioplasty, PTA with or without stent implantation).
In coronary artery disease, stents eluting anti-proliferative drugs (drug eluting stents, DES) reduce restenosis and improve clinical results for the majority of patients. Drug eluting balloons (DEB) are a promising alternative, but there is still little evidence that DES or DEB technology improve clinical outcome in PAD. However, promising results utilizing these new technologies in PAD have been reported in a few studies.
In this trial, we test the hypothesis that drug eluting (DE) technology is superior to conventional endovascular treatment (no-DE) in terms of important clinical outcomes, when applied on infrainguinal (femoropopliteal and/or infrapopliteal) obstructive vascular lesions. The trial consists of 2 separate parallel studies, SWEDEPAD 1 and SWEDEPAD 2, each defined by the severity of peripheral arterial disease. Patients with critical limb ischemia are allocated to SWEDEPAD 1 and patients with intermittent claudication are allocated to SWEDEPAD 2.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Revascularization with drug eluting technology | Experimental | Procedure: Revascularization with drug-eluting technology, Device: drug-coated balloons and/or drug-eluting stentsRevascularization with drug eluting technology |
| Revascularization without drug elution | Active comparator | Procedure: Revascularization without drug-eluting technologyRevascularization without drug elution technology |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All adults > 18 years old willing to be randomized
- Symptomatic PAD (critical limb ischemia or intermittent claudication) caused by >50% stenosis or occlusion of infrainguinal arteries and eligible for endovascular treatment according to established indications
Key exclusion criteria (4 listed)
- Acute thromboembolic disease in the leg
- Infrainguinal aneurysmal disease
- Previous participation in the study or in other randomised interventional study of infrainguinal lesions
- Patients without a Swedish personal identification number
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 |
|---|---|---|
| Revascularization with drug-eluting technologyEndovascular intervention with the use of drug-eluting devices (drug-coated balloons and/or drug-eluting stents). | Procedure or surgery | Revascularization with drug eluting technology |
| Revascularization without drug-eluting technologyEndovascular intervention without using drug-eluting balloons or stents | Procedure or surgery | Revascularization without drug elution |
| drug-coated balloons and/or drug-eluting stents | Device | Revascularization with drug eluting technology |
Primary outcome
Amputation rate (SWEDEPAD 1)
Time frame: Assessed when all patients have been followed for at least one year
Primary endpoint for patients with critical limb ischemia (SWEDEPAD 1) is amputation rate during follow-up, analysed when all patients have been followed for at least one year.
Health-related quality of life (SWEDEPAD 2)
Time frame: Assessed one year after randomization
Primary endpoint for patients with intermittent claudication (SWEDEPAD 2) is health-related quality of life after one year, assessed with VascuQol-6, a disease-specific health related quality of life instrument in PAD.
9 secondary outcomes
Amputation-free survival
Time frame: Assessed when all participants have been followed for at least one, three and five years.
Survival
Time frame: Assessed when all participants have been followed for at least one, three and five years.
Target lesion revascularization (TLR)
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Time to target lesion revascularization
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years.
Patency
Time frame: Assessed after 1 month and 1 year
Improvement in clinical symptoms, assessed with the Rutherford classification
Time frame: Assessed after one month and one year
Health-related quality of life (SWEDEPAD 1)
Time frame: Assessed after one year following randomisation
Amputation rate (SWEDEPAD 2)
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
Health-economic assessment
Time frame: Assessed one year after the intervention and when all participants have been followed for one, three and five years
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 Aug 2025.
- Derived from this study: PubMed 42779544Sellgren F, Falkenberg M, Andersson M, Andersson M, Le Corvec T, Delle M, Engstrom J, Fransson T, Hilbertson A, Horer TM, Jacobsson E, James S, Kragsterman B, Lindback J, Lindgren H, Mellander S, Olin R, Sigvant B, Skoog P, Smedberg C, Starck J, Tegler G, Thorbjornsen K, Truedson M, Tornqvist P, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J. Paclitaxel-Coated Devices in Patients With Chronic Limb-Threatening Ischemia and Tissue Loss Undergoing Infrainguinal Endovascular Revascularization: Insights From the SWEDEPAD-1 Trial. Circ Cardiovasc Interv. 2026 Sep 24:e016977. doi: 10.1161/CIRCINTERVENTIONS.126.016977. Online ahead of print.
- Derived from this study: PubMed 42573020Ma GW, Bernatchez J, Yarranton B, Dueck AD, Rajan DK, Forbes TL, de Mestral C, Kayssi A. Drug-eluting balloon angioplasty versus uncoated balloon angioplasty for peripheral arterial disease of the lower limbs. Cochrane Database Syst Rev. 2026 Aug 10;8:CD011319. doi: 10.1002/14651858.CD011319.pub3.
- Derived from this study: PubMed 42456888Le Corvec T, Falkenberg M, Gillgren P, James S, Lindback J, Lindgren H, Sellgren F, Skoog P, Wahlgren CM, Nordanstig J; SWEDEPAD Steering Committee. Impact of Paclitaxel Coated Devices on Limb Salvage and Target Vessel Revascularisation Rates following Isolated Femoropopliteal or Infrapopliteal Endovascular Revascularisation for Chronic Limb Threatening Ischaemia: Insights from the SWEDEPAD 1 Trial. Eur J Vasc Endovasc Surg. 2026 Jul 15:S1078-5884(26)00701-X. doi: 10.1016/j.ejvs.2026.07.023. Online ahead of print.
- Derived from this study: PubMed 40902617Falkenberg M, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Nordanstig J; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in chronic limb-threatening ischaemia (SWEDEPAD 1): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1103-1114. doi: 10.1016/S0140-6736(25)01585-5. Epub 2025 Aug 31.
- Derived from this study: PubMed 40902614Nordanstig J, James S, Andersson M, Andersson M, Delle M, Engstrom J, Fransson T, Gillgren P, Hilbertson A, Horer TM, Jacobsson E, Kragsterman B, Lindback J, Lindgren H, Ludwigs K, Mellander S, Nelzen O, Olin R, Sigvant B, Skoog P, Starck J, Tegler G, Thorbjornsen K, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M; SWEDEPAD trial investigators. Paclitaxel-coated versus uncoated devices for infrainguinal endovascular revascularisation in patients with intermittent claudication (SWEDEPAD 2): a multicentre, participant-masked, registry-based, randomised controlled trial. Lancet. 2025 Sep 13;406(10508):1115-1127. doi: 10.1016/S0140-6736(25)01584-3. Epub 2025 Aug 31.
- Derived from this study: PubMed 33296560Nordanstig J, James S, Andersson M, Andersson M, Danielsson P, Gillgren P, Delle M, Engstrom J, Fransson T, Hamoud M, Hilbertson A, Johansson P, Karlsson L, Kragsterman B, Lindgren H, Ludwigs K, Mellander S, Nyman N, Renlund H, Sigvant B, Skoog P, Starck J, Tegler G, Toivola A, Truedson M, Wahlgren CM, Wallinder J, Ojersjo A, Falkenberg M. Mortality with Paclitaxel-Coated Devices in Peripheral Artery Disease. N Engl J Med. 2020 Dec 24;383(26):2538-2546. doi: 10.1056/NEJMoa2005206. Epub 2020 Dec 9.
Related trials for Peripheral Arterial Disease
Active, not recruiting
SUCCESS (SelUtion, Safety, effiCaCy, hEalth economicS and promS) PTA Study
Peripheral Artery Disease
RecruitingPhase 3
Reducing Adverse Vascular Outcomes With Factor XI Inhibition in Adult Participants With Peripheral Artery Disease
Peripheral Artery Disease (PAD)
Recruiting
The THOR IDE Study
Peripheral Artery Disease, Peripheral Artery Stenosis
Not yet recruiting
Daily Stretching to Improve Walking in Older Patients With Peripheral Artery Disease: The STRETCH PAD Study
Peripheral Artery Disease (PAD), Intermittent Claudication
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
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.
Mårten Falkenberg, MD, PhD principal investigator
Department of Radiology, Sahlgrenska University Hospital
Joakim Nordanstig, MD study chair
Department of Vascular Surgery, Sahlgrenska University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Revascularization with drug-eluting technology, Revascularization without drug-eluting technology and drug-coated balloons and/or drug-eluting stents in people with Peripheral Arterial Disease and Critical Limb Ischemia, run by Sahlgrenska University Hospital at 1 site 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 2 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 Aug 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 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. 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?
Amputation rate (SWEDEPAD 1) (time frame: Assessed when all patients have been followed for at least one year). 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 NCT02051088, which also lists 6 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 Aug 2025.