Peripheral Arterial Disease Clinical Trial
— SUPEROfficial title:
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
Verified date | February 2018 |
Source | Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Terminated |
Enrollment | 240 |
Est. completion date | May 2016 |
Est. primary completion date | May 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age 18 years or older; 2. Disabling claudication as defined by surgeon based on patient's history; 3. Ankle/Brachial Index (ABI) < 0.9 or drop in ABI > 0.15 after exercise test; 4. 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; 5. 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; 6. Lesion classified A, B or C according to the TASC (TransAtlantic Inter-Society Consensus) classification of aortoiliac lesions; 7. Patient is able to walk at least 2 minutes on a treadmill at 3.2 km/h and 10% incline; 8. The Maximum Walking Distance on a treadmill < 300 meters. Exclusion Criteria: 1. Life expectancy < 3 months; 2. Patient is unable to complete self-reported questionnaires (insufficiently reading or speaking the Dutch language, cognitive disorders, etc); 3. Patient is unable to give informed consent; 4. A documented contrast allergy; 5. Pregnancy; 6. Contra-indication for anticoagulant therapy; 7. Duration of current complaints < 3 months; 8. Occlusion of the common femoral artery at the affected side; 9. Patient participates in another study; 10. 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); 11. Patient previously received Supervised Exercise Therapy (SET) according to KNGF (Dutch Society for Physiotherapists) guidelines; 12. Renal insufficiency (serum creatinin > 150 micromol/l). |
Country | Name | City | State |
---|---|---|---|
Netherlands | Flevoziekenhuis | Almere | |
Netherlands | Academic Medical Center | Amsterdam | |
Netherlands | Onze Lieve Vrouwe Gasthuis | Amsterdam | |
Netherlands | Sint Lucas Andreas Ziekenhuis | Amsterdam | |
Netherlands | VU Medical Center | Amsterdam | |
Netherlands | Gelre ziekenhuizen | Apeldoorn | |
Netherlands | Ziekenhuis Rijnstate | Arnhem | |
Netherlands | Rode Kruis Ziekenhuis | Beverwijk | |
Netherlands | Deventer Ziekenhuis | Deventer | |
Netherlands | Kennemer Gasthuis | Haarlem | |
Netherlands | Tergooiziekenhuizen | Hilversum | |
Netherlands | Spaarne Ziekenhuis | Hoofddorp | |
Netherlands | St Antonius Ziekenhuis | Nieuwegein | |
Netherlands | UMC St. Radboud | Nijmegen | |
Netherlands | Waterland ziekenhuis | Purmerend |
Lead Sponsor | Collaborator |
---|---|
M.J.W. Koelemaij | ZonMw: The Netherlands Organisation for Health Research and Development |
Netherlands,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Disease specific Quality of Life | 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 | |
Primary | Maximum Walking Distance | 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 | |
Secondary | Painfree Walking Distance | 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 | |
Secondary | Functional Status | 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 | |
Secondary | Generic Quality of Life | 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 | |
Secondary | Complications | Complications related to both interventions during 12 months. | During 12 months | |
Secondary | Treatment failures | A treatment failure is defined as crossover to the other treatment arm. | During 12 months | |
Secondary | Costs | Costs during 1 year. | During 12 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06032065 -
Sequential Multiple Assessment Randomized Trial of Exercise for PAD: SMART Exercise for PAD (SMART PAD)
|
Phase 3 | |
Active, not recruiting |
NCT03987061 -
MOTIV Bioresorbable Scaffold in BTK Artery Disease
|
N/A | |
Recruiting |
NCT03506633 -
Impacts of Mitochondrial-targeted Antioxidant on Peripheral Artery Disease Patients
|
N/A | |
Active, not recruiting |
NCT03506646 -
Dietary Nitrate Supplementation and Thermoregulation
|
N/A | |
Active, not recruiting |
NCT04677725 -
NEtwork to Control ATherothrombosis (NEAT Registry)
|
||
Recruiting |
NCT05961943 -
RESPONSE-2-PAD to Reduce Sedentary Time in Peripheral Arterial Disease Patients
|
N/A | |
Recruiting |
NCT06047002 -
Personalised Antiplatelet Therapy for Patients With Symptomatic Peripheral Arterial Disease
|
||
Completed |
NCT03185052 -
Feasibility of Outpatient Care After Manual Compression in Patients Treated for Peripheral Arterial Disease by Endovascular Technique With 5F Sheath Femoral Approach
|
N/A | |
Recruiting |
NCT05992896 -
A Study of Loco-Regional Liposomal Bupivacaine Injection
|
Phase 4 | |
Completed |
NCT04635501 -
AbsorbaSeal (ABS 5.6.7) Vascular Closure Device Trial
|
N/A | |
Recruiting |
NCT04584632 -
The Efemoral Vascular Scaffold System (EVSS) for the Treatment of Patients With Symptomatic Peripheral Vascular Disease From Stenosis or Occlusion of the Femoropopliteal Artery
|
N/A | |
Withdrawn |
NCT03994185 -
The Merit WRAPSODY™ Endovascular Stent Graft for Treatment of Iliac Artery Occlusive Disease
|
N/A | |
Withdrawn |
NCT03538392 -
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
|
||
Recruiting |
NCT02915796 -
Autologous CD133(+) Cells as an Adjuvant to Below the Knee Percutaneous Transluminal Angioplasty
|
Phase 1 | |
Active, not recruiting |
NCT02900924 -
Observational Study to Evaluate the BioMimics 3D Stent System: MIMICS-3D
|
||
Completed |
NCT02901847 -
To Evaluate the Introduction of a Public Health Approach to Peripheral Arterial Disease (PAD) Using National Centre for Sport and Exercise Medicine Facilities.
|
N/A | |
Not yet recruiting |
NCT02455726 -
Magnesium Oral Supplementation to Reduce Pain Inpatients With Severe Peripheral Arterial Occlusive Disease
|
N/A | |
Not yet recruiting |
NCT02387450 -
Reduced Cardiovascular Morbi-mortality by Sildenafil in Patients With Arterial Claudication
|
Phase 2/Phase 3 | |
Withdrawn |
NCT02126540 -
Trial of Pantheris System, an Atherectomy Device That Provides Imaging While Removing Plaque in Lower Extremity Arteries
|
N/A | |
Completed |
NCT02022423 -
Physical Activity Daily - An Internet-Based Walking Program for Patients With Peripheral Arterial Disease
|
N/A |