- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT01385774
SUPER Study; SUPERvised Exercise or Angioplasty for Intermittent Claudication Due to an Iliac Artery Obstruction. (SUPER)
SUPERvised Exercise Therapy (SET) or Immediate Percutaneous Transluminal Angioplasty (PTA) for Intermittent Claudication (IC) in Patients With an Iliac Artery Obstruction: A Randomized Controlled Trial. SUPER Study
The purpose of our study is to compare the clinical effectiveness and cost-effectiveness of two treatment strategies of Intermittent Claudication (IC) due to an iliac artery obstruction: to start with SUPERvised Exercise Therapy (SET) and deferred Percutaneous Transluminal Angioplasty (PTA) in case of SET failure, or immediate PTA.
It is our hypothesis that PTA as first line treatment is more effective than SET as first line treatment with regard to maximum walking distance, quality of life and costs after one year.
Visão geral do estudo
Status
Intervenção / Tratamento
Descrição detalhada
Intermittent claudication (IC) is a manifestation of cardiovascular disease, reflected by a threefold increased risk in these patients of developing serious cardiovascular events. Treatment of patients with IC is aimed at secondary prevention of cardiovascular events by control of risk factors for atherosclerotic disease, and to improve walking distance and subsequently quality of life. Supervised Exercise Therapy (SET) and Percutaneous Transluminal Angioplasty (PTA) can effectively improve pain free walking distance, but the optimal choice of treatment, specifically in patients with an iliac artery stenosis or occlusion is unclear. PTA is attractive as initial therapy since PTA of the iliac arteries has an immediate effect and it is durable. There is a lack of evidence from randomized controlled trials (RCT) to define the optimal treatment strategy for patients with IC due to iliac artery lesions; first line treatment with SET and PTA in case of failure, or immediate iliac artery PTA.
Purpose:
To define the optimal treatment strategy of IC due to an iliac artery obstruction: To start with SET and deferred PTA in case of SET failure, or immediate PTA.
Design:
Multicenter randomized controlled trial.
Patients:
400 patients with IC due to an iliac artery stenosis or occlusion.
Interventions:
SET and PTA.
Outcomes:
Primary outcomes are quality of life (Qol) recorded with the disease specific VascuQol instrument and maximum walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline after 1 year.
Secondary outcomes are pain-free walking distance, generic Qol, functional status, complications, number of treatment failures and costs. Economic evaluation comprises a cost-effectiveness and cost-utility analysis from a societal perspective, with the costs per patient able to walk maximal, respectively the costs per Quality Adjusted Life-Year (QALY) as outcome measures.
Tipo de estudo
Inscrição (Real)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
-
-
-
Almere, Holanda, 1315 RA
- Flevoziekenhuis
-
Amsterdam, Holanda, 1105 AZ
- Academic Medical Center
-
Amsterdam, Holanda, 1091 AC
- Onze Lieve Vrouwe Gasthuis
-
Amsterdam, Holanda, 1081 HV
- VU Medical Center
-
Amsterdam, Holanda, 1061 AE
- Sint Lucas Andreas Ziekenhuis
-
Apeldoorn, Holanda, 7334 DZ
- Gelre Ziekenhuizen
-
Arnhem, Holanda, 6815 AD
- Ziekenhuis Rijnstate
-
Beverwijk, Holanda, 1942 LE
- Rode Kruis Ziekenhuis
-
Deventer, Holanda, 7416 SE
- Deventer Ziekenhuis
-
Haarlem, Holanda, 2035 RC
- Kennemer Gasthuis
-
Hilversum, Holanda, 1213 XZ
- Tergooiziekenhuizen
-
Hoofddorp, Holanda, 2134 TM
- Spaarne Ziekenhuis
-
Nieuwegein, Holanda, 3435 CM
- St Antonius Ziekenhuis
-
Nijmegen, Holanda, 6525 GA
- UMC St. Radboud
-
Purmerend, Holanda, 1441 RN
- Waterland Ziekenhuis
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
- Age 18 years or older;
- Disabling claudication as defined by surgeon based on patient's history;
- Ankle/Brachial Index (ABI) < 0.9 or drop in ABI > 0.15 after exercise test;
- Hemodynamic stenosis of the common or external iliac artery on Color Duplex Scanning (CDS) (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on Magnetic Resonance Angiography (MRA) or Computed Tomography Angiography (CTA)(> 50% stenosis) or occlusion of the common or external iliac artery on CDS (PSV 0 m/s) or on MRA or CTA;
- Iliac artery lesion and a concomitant stenosis in the superficial femoral artery defined as stenosis > 50% by CDS (PSV ratio ≥ 2.5 or EDV ≥ 0.6 m/s) or on MRA or CTA, or occlusion on CDS (PSV 0 m/s) or MRA or CTA;
- Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society Consensus) classification of aortoiliac lesions;
- Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline;
- The Maximum Walking Distance on a treadmill < 300 meters.
Exclusion Criteria:
- Life expectancy < 3 months;
- Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc);
- Patient is unable to give informed consent;
- A documented contrast allergy;
- Pregnancy;
- Contra-indication for anticoagulant therapy;
- Duration of current complaints < 3 months;
- Occlusion of the common femoral artery at the affected side;
- Patient participates in another study;
- Heart failure or Angina Pectoris NYHA III or IV. (NYHA III: Marked limitation of physical activity. Comfortable at rest, but less than ordinary activity causes fatigue, palpitation, or dyspnea; NYHA IV: Unable to carry out any physical activity without discomfort. Symptoms of cardiac insufficiency at rest. If any physical activity is undertaken, discomfort is increased);
- Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch Society for Physiotherapists) guidelines;
- Renal insufficiency (serum creatinin > 150 micromol/l).
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
---|---|
Comparador Ativo: Intervention group: Angioplasty
Angioplasty with or without stent of the iliac artery
|
The Percutaneous Transluminal Angioplasty (PTA) procedure will be performed by an experienced interventional radiologist using a conventional guide wire and balloon catheter technique.
A stent will be placed in cases in which the residual mean pressure gradient is greater than 10 mmHg across the treated site or when more than 30% stenosis after the procedure is detected.
All PTA patients are encouraged perform at least three walking sessions every day.
Outros nomes:
|
Comparador Ativo: Control: Supervised Exercise Therapy
Supervised exercise therapy by a physiotherapist
|
Supervised Exercise Therapy (SET) will take place in the hospital or community based according to the guidelines of the Dutch Society for Physiotherapists.
The duration of the treatment will be at least 6 months and with a frequency of 2 times a week for at least 60 minutes and an intensity near maximum pain barrier (defined as pain of which it is not possible to be distracted).
The frequency of the training will decrease after 3 months and the patients will receive homework, make a plan and keep a log of their exercise activities.
Furthermore the program consists of walking pattern improvement and enhancement of endurance and strength.
All SET patients are encouraged to perform at least three walking sessions every day on their own.
Outros nomes:
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Disease specific Quality of Life
Prazo: 12 months
|
Disease specific Quality of life (Qol) recorded with the disease specific VascuQol instrument 1 year after intervention. The VascuQol will be completed at baseline and 1,6,12 months follow-up. |
12 months
|
Maximum Walking Distance
Prazo: 12 months
|
Maximum walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline measured 1 year after intervention. The maximum walking distance will be assessed at baseline and 1,6,12 months follow-up. |
12 months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
---|---|---|
Painfree Walking Distance
Prazo: 12 months
|
Painfree walking distance on a standardized treadmill test with a speed of 3.2 km/h at 10% incline 1 year after intervention. The painfree walking distance will be assessed at baseline and 1,6,12 months follow-up. |
12 months
|
Functional Status
Prazo: 12 months
|
Functional status assessed by the AMC Linear Disability Score (ALDS) 1 year after intervention. The ALDS will be completed at baseline and 1,6,12 months follow-up. |
12 months
|
Generic Quality of Life
Prazo: 12 months
|
Generic quality of life (Qol) recorded with the Short Form 36 (SF-36) and EQ-5D (former EuroQoL). The SF-36 will be completed at baseline and 1,6,12 months follow-up. The EQ-5D will be completed at baseline, 1 week and 1,6,12 months follow-up. |
12 months
|
Complications
Prazo: During 12 months
|
Complications related to both interventions during 12 months.
|
During 12 months
|
Treatment failures
Prazo: During 12 months
|
A treatment failure is defined as crossover to the other treatment arm.
|
During 12 months
|
Costs
Prazo: During 12 months
|
Costs during 1 year.
|
During 12 months
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Mark JW Koelemay, M.D., Ph.D, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Jim A Reekers, M.D., Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigador principal: Dink A Legemate, M.D.,Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Diretor de estudo: Shandra Bipat, Ph.D., Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Publicações e links úteis
Publicações Gerais
- Frans FA, Zagers MB, Jens S, Bipat S, Reekers JA, Koelemay MJ. The relationship of walking distances estimated by the patient, on the corridor and on a treadmill, and the Walking Impairment Questionnaire in intermittent claudication. J Vasc Surg. 2013 Mar;57(3):720-727.e1. doi: 10.1016/j.jvs.2012.09.044. Epub 2013 Jan 11.
- Frans FA, Bipat S, Reekers JA, Legemate DA, Koelemay MJ; SUPER Study Collaborators. SUPERvised exercise therapy or immediate PTA for intermittent claudication in patients with an iliac artery obstruction--a multicentre randomised controlled trial; SUPER study design and rationale. Eur J Vasc Endovasc Surg. 2012 Apr;43(4):466-71. doi: 10.1016/j.ejvs.2012.01.014. Epub 2012 Feb 10.
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 171102025;ZonMw
- 09/285;METC AMC (Outro identificador: Protocol number; IRB AMC Amsterdam)
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .
Ensaios clínicos em Doença arterial periférica
-
Mayo ClinicInscrevendo-se por conviteAnatomia da GSV para Rescue Peripheral IV AccessEstados Unidos
-
Dartmouth-Hitchcock Medical CenterDartmouth CollegeConcluídoPressão arterial | Anestesia | Linha arterialEstados Unidos
-
BLZ Technology (Wuhan) Co.,LtdAinda não está recrutandoPressão arterial | Anestesia geral | Linha arterial | Pulsação
-
AHEPA University HospitalConcluídoRigidez Arterial | Monitorização Ambulatorial da Pressão ArterialGrécia
-
Auburn UniversityAtivo, não recrutandoDorme | Pressão arterial | Disfunção Endotelial | Racismo | Rigidez ArterialEstados Unidos
-
Unity Health TorontoConcluídoRigidez Arterial, Pressão ArterialCanadá
-
Istituto Auxologico ItalianoRecrutamentoHipertensão arterial | Monitorização Ambulatorial da Pressão Arterial | Determinação da pressão arterial | Monitoramento residencial da pressão arterialItália
-
ROX Medical, Inc.ConcluídoHipertensão | Pressão Arterial, Alta | Pressão Arterial, Resistente | Pressão Arterial, DescontroladaReino Unido, Holanda, Bélgica
-
DongGuk UniversityAtivo, não recrutandoHipertensão | Pressão arterial | Pressão Arterial Ambulatorial | Medição de pressão arterial em casaRepublica da Coréia
-
University of JyvaskylaBusiness Finland; Finnish Foundation for Cardiovascular Research; Harvia Finland...ConcluídoPressão arterial | Fator de Risco Cardiovascular | Rigidez ArterialFinlândia
Ensaios clínicos em Percutaneous Transluminal Angioplasty
-
AtheroMed, IncConcluídoDoença vascular periféricaEstados Unidos, Alemanha
-
National Heart, Lung, and Blood Institute (NHLBI)ConcluídoDoença Cardíaca Estrutural | Doença Arterial Coronária Obstrutiva | Doença Arterial Periférica ObstrutivaEstados Unidos
-
University of CreteConcluídoÚlceras isquêmicas do pé
-
ArthesysConcluídoEstenose da Artéria CoronáriaFrança
-
Heinrich-Heine University, DuesseldorfGerman Diabetes CenterRecrutamentoDiabetes Mellitus | Pé diabético | Neuropatias diabéticas | Doença arterial periférica | Anemia | Retinopatia diabética | Polineuropatia diabética | Úlcera no pé | Úlcera IsquêmicaAlemanha
-
University Hospital Inselspital, BerneUniversity of BernRetiradoDoenças Vasculares Periféricas
-
Cairo UniversityAtivo, não recrutando
-
Sight Sciences, Inc.DesconhecidoGlaucoma de Ângulo AbertoEstados Unidos
-
Chinese Pulmonary Vascular Disease Research GroupRecrutamentoArterite de Takayasu com envolvimento da artéria pulmonar | Angioplastia Pulmonar Transluminal Percutânea | Medicação direcionada para PAHChina
-
University Hospitals Cleveland Medical CenterConcluídoDoenças prostáticas | Corpo Estranho Gástrico, Nºs | Distúrbio do Abdômen (Desordem) | Corpo estranho no esôfago | Doença do Intestino DelgadoEstados Unidos