Peripheral Vascular DiseasePhase 2/3PADINCT00471289

PTA and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

A Phase 2/3 study testing PTA with placement of paclitaxel-eluting stent and PTA in people with Peripheral Vascular Disease, run by Netherlands Society for Interventional Radiology at 3 sites in Netherlands.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

Search all trials

Trial summary

The purpose of this study is to investigate the performance of paclitaxel-coated balloon expandable stainless steel coronary stent for the treatment of infrapopliteal stenoses and occlusions in patients with critical limb ischemia compared to percutaneous transluminal balloon angioplasty (PTA). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Peripheral Vascular Disease
What is being tested?: PTA with placement of paclitaxel-eluting stent and PTA
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 144 participants
Where: 3 sitesNetherlands
Study dates: Aug 2007to Mar 2023
Phase: Phase 2/3
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

Written informed consent
Age > 18 years
If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
Patient is willing and able to comply with the specified follow-up evaluation
Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)
Stenotic (>50% luminal loss) or occluded infrapopliteal artery, including the tibiofibular trunk, the anterior tibial artery, the posterior tibial artery and the peroneal artery, with a lesion length ≤ 60 mm

Show all 9Show fewer

Artery to be treated with a diameter more tham or equal to 2mm and less than or equal to 4mm
Patent common iliac, external iliac, superficial femoral and popliteal artery on the ipsilateral side prior to randomisation, possibly after treatment during the same session
At least one patent crural (anterior tibial, posterior tibial or peroneal) artery with expected unobstructed runoff to ankle level after treatment

Who cannot join

Acute limb ischaemia
Subacute limb ischaemia which requires thrombolysis as first treatment modality
Active bleeding or bleeding diathesis
Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair
Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment
Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side

Show all 20Show fewer

Revascularization involving the same limb within 30 days prior to the index procedure or planned revascularization of the same limb within 30 days of the index procedure
Previous implanted stent at the index site
Life expectancy of less than 6 months or other factors making clinical follow-up difficult
Known allergy to acetylsalicylic acid (aspirin), clopidogrel, heparin or paclitaxel
Known allergy to contrast media
Known heparin induced thrombocytopenia (HIT type 2)
Patient unable or unwilling to tolerate anticoagulant, anti-platelet therapy or contrast media
Creatinine clearance < 20 ml/min (as derived from Cockcroft-Gault or MDRD formula)unless patient is on hemodialysis
Aneurysm in common femoral, superficial femoral or popliteal artery on the ipsilateral side
Severely calcified lesions with expected resistance to stenting
Poor inflow due to ipsilateral stenoses or occlusions of the iliac or femoropopliteal arteries that cannot be treated during the same session
Significant vessel tortuosity or other parameters prohibiting access to the lesions and/or delivery of the stent
Patients without (expected) distal runoff to the index site
Previous implanted stent at the index site

Trial locations and contacts

3 sites in 1 country.

Netherlands3 sites

Sint Antonius Ziekenhuis
Nieuwegein, Utrecht
HagaZiekenhuis, location Leyweg
The Hague, South Holland, 2545CH
University Medical Center Utrecht (UMCU)
Utrecht, 3584 CX

Other trials in Netherlands

About this study

Official title: Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia

Read the detailed description

Critical limb ischemia (CLI) is a serious condition that is becoming more and more common in the western world due to the growing percentage of elderly in the population and the rising incidence of diabetes. In about 40% of patients a stenosis or occlusion in the arteries below the level of the knee will be present. Restoration of blood flow is imperative to allow pain relief and tissue healing. Without revascularization patients with CLI are at risk for limb loss and potentially fatal complications such as sepsis.

In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant restenosis is found in approximately 50% after 6 months.

In interventional cardiology a significant reduction in restenosis rates in coronary arteries has been found using drug eluting stents (DES), including the paclitaxel eluting stent (TAXUS, Boston Scientific). DES locally deliver drugs (e.g. paclitaxel) that interfere with the restenosis process.

Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI may improve patency and clinical outcome.

Comparison:

Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA.

Conditions: Peripheral Vascular Disease
Being tested: PTA with placement of paclitaxel-eluting stent, PTA
Keywords: Critical Limb Ischemia, Stents, Drug Eluting Stents, Peripheral arterial disease, PAD, Paclitaxel, TAXUS, Infrapopliteal, Infragenicular, Interventional Radiology, CLI, DES
Medical subject headings: Peripheral Vascular Diseases, Chronic Limb-Threatening Ischemia, Peripheral Arterial Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PTA with placement of paclitaxel-eluting stentDevice
PTA with placement of paclitaxel-eluting stent
PTADevice
PTA

Study groups in NCT00471289
Study group	Role	What they receive
1	Experimental	PTA with primary placement of Drug (paclitaxel) Eluting Stent Receives: Device: PTA with placement of paclitaxel-eluting stent
2	Active comparator	PTA Receives: Device: PTA

What is being measured

The primary outcome is the main question the study is designed to answer.

The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim.
Measured: 6 months

Secondary outcomes (13)

Primary patency of the treated sites at 3, 6 and 12 months after intervention assessed by duplex sonography (binary patency, <50% stenosis defined as PSV ratio <2.0)
Measured: 3, 6, 12 months
Clinical evaluation of the treated ischemic leg at 3, 6 and 12 months.
Measured: 3, 6, 12 months
Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12 months
Measured: 3, 6, 12 months
Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months.
Measured: 3, 6, 12 months
Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months.
Measured: 3, 6, 12 months
Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12 months.
Measured: 3, 6, 12 months
Peri-procedural (within 30 days) complications.
Measured: 30 days
Death.
Measured: 3, 6, 12 months
Clinical assessment primarily by Rutherford score for peripheral arterial disease
Clinical assessment outpatient clinic
Measured: 2, 3, 4 and 5 years after treatment
Target lesion patency by means of duplex sonography
During outpatient clinic visits
Measured: 2, 3, 4 and 5 years after treatment
Major amputation (at or above the ankle) of treated limb
Assessment up to 5 years after treatment during outpatient clinic visits From 5 to 10 years by means of yearly evaluation of patient charts
Measured: yearly up to 10 years after treatment
Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months.
From 2 to 5 years during outpatient clinic visits From 5 to 10 years yearly evaluation of patient charts
Measured: yearly up to 10 years after treatment
Endovascular or surgical re-intervention of target lesion
Follow-up until first re-intervention of target lesion
Measured: 3, 6, 12 months, 2,3,4 and 5 years after inclusion

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2007Mar 2023

First posted9 May 2007 (estimated)
Study startAug 2007
Primary completionSep 2013
Study completionMar 2023 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (19)Papers the sponsor has linked to this study.
Other trials for Peripheral Vascular 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 2/3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 144 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00471289
Sponsor's protocol ID: PADI/200601
Acronym: PADI
Status last verified: Sep 2020
First submitted: 7 May 2007
Last updated: 16 Sep 2020
Results posted: No
Data monitoring committee: No

Publications

Management of peripheral arterial disease (PAD). TransAtlantic Inter-Society Consensus (TASC). Section D: chronic critical limb ischaemia. Eur J Vasc Endovasc Surg. 2000 Jun;19 Suppl A:S144-243. No abstract available.
PubMed 10957907
Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.
PubMed 16325694
Jensen SA, Vatten LJ, Myhre HO. The prevalence of chronic critical lower limb ischaemia in a population of 20,000 subjects 40-69 years of age. Eur J Vasc Endovasc Surg. 2006 Jul;32(1):60-5. doi: 10.1016/j.ejvs.2005.12.022. Epub 2006 Mar 2.
PubMed 16513377
Black JH 3rd, LaMuraglia GM, Kwolek CJ, Brewster DC, Watkins MT, Cambria RP. Contemporary results of angioplasty-based infrainguinal percutaneous interventions. J Vasc Surg. 2005 Nov;42(5):932-9. doi: 10.1016/j.jvs.2005.06.024.
PubMed 16275450
Sigala F, Menenakos Ch, Sigalas P, Baunach Ch, Langer S, Papalambros E, Hepp W. Transluminal angioplasty of isolated crural arterial lesions in diabetics with critical limb ischemia. Vasa. 2005 Aug;34(3):186-91. doi: 10.1024/0301-1526.34.3.186.
PubMed 16184838
Hynes N, Mahendran B, Manning B, Andrews E, Courtney D, Sultan S. The influence of subintimal angioplasty on level of amputation and limb salvage rates in lower limb critical ischaemia: a 15-year experience. Eur J Vasc Endovasc Surg. 2005 Sep;30(3):291-9. doi: 10.1016/j.ejvs.2005.04.020.
PubMed 15939635
Eskelinen E, Alback A, Roth WD, Lappalainen K, Keto P, Railo M, Eskelinen A, Lepantalo M. Infra-inguinal percutaneous transluminal angioplasty for limb salvage: a retrospective analysis in a single center. Acta Radiol. 2005 Apr;46(2):155-62. doi: 10.1080/02841850510022705.
PubMed 15902890
Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041.
PubMed 15838475
Atar E, Siegel Y, Avrahami R, Bartal G, Bachar GN, Belenky A. Balloon angioplasty of popliteal and crural arteries in elderly with critical chronic limb ischemia. Eur J Radiol. 2005 Feb;53(2):287-92. doi: 10.1016/j.ejrad.2004.02.016.
PubMed 15664294
Tsetis D, Belli AM. The role of infrapopliteal angioplasty. Br J Radiol. 2004 Dec;77(924):1007-15. doi: 10.1259/bjr/97382129.
PubMed 15569642
Matsagas MI, Rivera MA, Tran T, Mitchell A, Robless P, Davies AH, Geroulakos G. Clinical outcome following infra-inguinal percutaneous transluminal angioplasty for critical limb ischemia. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):251-5. doi: 10.1007/s00270-003-0007-z.
PubMed 14562973
Molloy KJ, Nasim A, London NJ, Naylor AR, Bell PR, Fishwick G, Bolia A, Thompson MM. Percutaneous transluminal angioplasty in the treatment of critical limb ischemia. J Endovasc Ther. 2003 Apr;10(2):298-303. doi: 10.1177/152660280301000220.
PubMed 12877613
Haider SN, Kavanagh EG, Forlee M, Colgan MP, Madhavan P, Moore DJ, Shanik GD. Two-year outcome with preferential use of infrainguinal angioplasty for critical ischemia. J Vasc Surg. 2006 Mar;43(3):504-512. doi: 10.1016/j.jvs.2005.11.016.
PubMed 16520164
Wiskirchen J, Schober W, Schart N, Kehlbach R, Wersebe A, Tepe G, Claussen CD, Duda SH. The effects of paclitaxel on the three phases of restenosis: smooth muscle cell proliferation, migration, and matrix formation: an in vitro study. Invest Radiol. 2004 Sep;39(9):565-71. doi: 10.1097/01.rli.0000133815.22434.55.
PubMed 15308939
Serruys PW, Kutryk MJ, Ong AT. Coronary-artery stents. N Engl J Med. 2006 Feb 2;354(5):483-95. doi: 10.1056/NEJMra051091. No abstract available.
PubMed 16452560

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Peripheral Vascular Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Percutaneous Transluminal Balloon Angioplasty (PTA) and Drug Eluting Stents for Infrapopliteal Lesions in Critical Limb Ischemia
ClinicalTrials.gov ID: NCT00471289
Acronym / sponsor ID: PADI / PADI/200601
Conditions: Peripheral Vascular Disease
Keywords: Critical Limb Ischemia, Stents, Drug Eluting Stents, Peripheral arterial disease, PAD, Paclitaxel, TAXUS, Infrapopliteal
Phase: Phase 2/3
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 144 participants (actual)
Lead sponsor: Netherlands Society for Interventional RadiologyUniversity, hospital or other
Study start: Aug 2007
Primary completion: Sep 2013 (actual)
Study completion: Mar 2023 (estimated)
First posted: 9 May 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.

Detailed description

In patients treated with percutaneous transluminal balloon angioplasty (PTA)significant restenosis is found in approximately 50% after 6 months.

Using DES in treating below the knee (infrapopliteal) arterial lesions in patients with CLI may improve patency and clinical outcome.

Comparison:

Treatment of below the knee arterial lesions in patients with CLI with PTA and DES compared to only PTA.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Device: PTA with placement of paclitaxel-eluting stentPTA with primary placement of Drug (paclitaxel) Eluting Stent
2	Active comparator	Device: PTAPTA

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Written informed consent
Age > 18 years
If female patient with child bearing potential, patient may not be pregnant at the study entry and must utilize reliable birth control for the duration of her participation into the study
Patient is willing and able to comply with the specified follow-up evaluation
Critical Limb Ischaemia, this is Fontaine stage III (ischaemic rest pain) and IV (ischaemic ulcers or gangrene) or Rutherford category 4 (ischaemic rest pain), 5 (minor tissue loss) or 6 (major tissue loss)

Key exclusion criteria (20 listed)

Acute limb ischaemia
Subacute limb ischaemia which requires thrombolysis as first treatment modality
Active bleeding or bleeding diathesis
Recent (less than 3 months) hemorrhagic stroke or other any other CNS abnormality with increased risk of haemorrhage, such as intracranial neoplasm, arteriovenous malformation, intracranial aneurysm or aneurysm repair
Gastrointestinal or genitourinary bleeding of clinical significance within the previous 6 weeks before treatment

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
PTA with placement of paclitaxel-eluting stentPTA with placement of paclitaxel-eluting stent	Device	1
PTAPTA	Device	2

Primary outcome

The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim.
Time frame: 6 months

13 secondary outcomes

Primary patency of the treated sites at 3, 6 and 12 months after intervention assessed by duplex sonography (binary patency, <50% stenosis defined as PSV ratio <2.0)
Time frame: 3, 6, 12 months
Clinical evaluation of the treated ischemic leg at 3, 6 and 12 months.
Time frame: 3, 6, 12 months
Major amputation (at or above the ankle) of the trial leg at 3, 6 and 12 months
Time frame: 3, 6, 12 months
Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months.
Time frame: 3, 6, 12 months
Infrapopliteal surgical bypass of the trial leg at 3, 6 and 12 months.
Time frame: 3, 6, 12 months
Infrapopliteal endovascular re-intervention of the trial leg at 3, 6 and 12 months.
Time frame: 3, 6, 12 months
Peri-procedural (within 30 days) complications.
Time frame: 30 days
Death.
Time frame: 3, 6, 12 months
Clinical assessment primarily by Rutherford score for peripheral arterial disease
Time frame: 2, 3, 4 and 5 years after treatment
Target lesion patency by means of duplex sonography
Time frame: 2, 3, 4 and 5 years after treatment
Major amputation (at or above the ankle) of treated limb
Time frame: yearly up to 10 years after treatment
Minor amputation (below the ankle excluding the toes) of the trial leg at 3, 6 and 12 months.
Time frame: yearly up to 10 years after treatment
Endovascular or surgical re-intervention of target lesion
Time frame: 3, 6, 12 months, 2,3,4 and 5 years after inclusion

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
Background: PubMed 10957907Management of peripheral arterial disease (PAD). TransAtlantic Inter-Society Consensus (TASC). Section D: chronic critical limb ischaemia. Eur J Vasc Endovasc Surg. 2000 Jun;19 Suppl A:S144-243. No abstract available.
Background: PubMed 16325694Adam DJ, Beard JD, Cleveland T, Bell J, Bradbury AW, Forbes JF, Fowkes FG, Gillepsie I, Ruckley CV, Raab G, Storkey H; BASIL trial participants. Bypass versus angioplasty in severe ischaemia of the leg (BASIL): multicentre, randomised controlled trial. Lancet. 2005 Dec 3;366(9501):1925-34. doi: 10.1016/S0140-6736(05)67704-5.
Background: PubMed 16513377Jensen SA, Vatten LJ, Myhre HO. The prevalence of chronic critical lower limb ischaemia in a population of 20,000 subjects 40-69 years of age. Eur J Vasc Endovasc Surg. 2006 Jul;32(1):60-5. doi: 10.1016/j.ejvs.2005.12.022. Epub 2006 Mar 2.
Background: PubMed 16275450Black JH 3rd, LaMuraglia GM, Kwolek CJ, Brewster DC, Watkins MT, Cambria RP. Contemporary results of angioplasty-based infrainguinal percutaneous interventions. J Vasc Surg. 2005 Nov;42(5):932-9. doi: 10.1016/j.jvs.2005.06.024.
Background: PubMed 16184838Sigala F, Menenakos Ch, Sigalas P, Baunach Ch, Langer S, Papalambros E, Hepp W. Transluminal angioplasty of isolated crural arterial lesions in diabetics with critical limb ischemia. Vasa. 2005 Aug;34(3):186-91. doi: 10.1024/0301-1526.34.3.186.
Background: PubMed 15939635Hynes N, Mahendran B, Manning B, Andrews E, Courtney D, Sultan S. The influence of subintimal angioplasty on level of amputation and limb salvage rates in lower limb critical ischaemia: a 15-year experience. Eur J Vasc Endovasc Surg. 2005 Sep;30(3):291-9. doi: 10.1016/j.ejvs.2005.04.020.
Background: PubMed 15902890Eskelinen E, Alback A, Roth WD, Lappalainen K, Keto P, Railo M, Eskelinen A, Lepantalo M. Infra-inguinal percutaneous transluminal angioplasty for limb salvage: a retrospective analysis in a single center. Acta Radiol. 2005 Apr;46(2):155-62. doi: 10.1080/02841850510022705.
Background: PubMed 15838475Kudo T, Chandra FA, Ahn SS. The effectiveness of percutaneous transluminal angioplasty for the treatment of critical limb ischemia: a 10-year experience. J Vasc Surg. 2005 Mar;41(3):423-35; discussion 435. doi: 10.1016/j.jvs.2004.11.041.
Background: PubMed 15664294Atar E, Siegel Y, Avrahami R, Bartal G, Bachar GN, Belenky A. Balloon angioplasty of popliteal and crural arteries in elderly with critical chronic limb ischemia. Eur J Radiol. 2005 Feb;53(2):287-92. doi: 10.1016/j.ejrad.2004.02.016.
Background: PubMed 15569642Tsetis D, Belli AM. The role of infrapopliteal angioplasty. Br J Radiol. 2004 Dec;77(924):1007-15. doi: 10.1259/bjr/97382129.
Background: PubMed 14562973Matsagas MI, Rivera MA, Tran T, Mitchell A, Robless P, Davies AH, Geroulakos G. Clinical outcome following infra-inguinal percutaneous transluminal angioplasty for critical limb ischemia. Cardiovasc Intervent Radiol. 2003 May-Jun;26(3):251-5. doi: 10.1007/s00270-003-0007-z.
Background: PubMed 12877613Molloy KJ, Nasim A, London NJ, Naylor AR, Bell PR, Fishwick G, Bolia A, Thompson MM. Percutaneous transluminal angioplasty in the treatment of critical limb ischemia. J Endovasc Ther. 2003 Apr;10(2):298-303. doi: 10.1177/152660280301000220.

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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.

Hans Van Overhagen, MD PhD principal investigator

HagaZiekenhuis Dept. of Radiology

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 9 inclusion and 20 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 16 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 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.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

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?

The primary endpoint will be primary patency of the treated site at 6 months. Primary patency is defined as <50% loss of luminal diameter at the treated site on CT arteriography (CTA) without re-intervention in the interim. (time frame: 6 months). 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 NCT00471289, which also lists 19 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 16 Sep 2020.