Peripheral Arterial Disease Clinical Trial
— IROADOfficial title:
Improving Radiological Outcomes in Arterial Disease - A Pilot Evaluation of the Pedra Tissue Perfusion Monitoring System
NCT number | NCT03294902 |
Other study ID # | CIP-01 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | May 30, 2018 |
Est. completion date | June 30, 2020 |
Verified date | September 2020 |
Source | Pedra Technology, PTE LTD |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The Pedra Technologies' PedraTM device is a non-invasive, diagnostic device intended to measure foot perfusion by assessing blood flow. The PedraTM device comprises a compact instrument console connected to a sensor that is pasted onto the patient's foot during perfusion assessment. Through skin contact, the device is able to monitor tissue perfusion at depths of up to 7.5mm. The monitor console contains opto-electronic instrumentation including coherent infrared light sources, photo detectors, and display/control electronics. The sensor comprises passive fiber-optic conduits, which transfer infrared light from the console to the patient, and relays scattered light from the patient back to the console. The intensity of light emitted from the sensor is less than 3 mW, well within the safety envelope of Class I laser systems and comparable (or lower than) other commercially available devices such as laser Doppler systems. The sole point of contact with the patient is a layer of medical grade adhesive tape, which is used to paste the flat sensor onto intact skin.
Status | Completed |
Enrollment | 68 |
Est. completion date | June 30, 2020 |
Est. primary completion date | December 31, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years to 90 Years |
Eligibility |
General Inclusion Criteria: 1. The patient is a male or non-pregnant female = 40 to 90 years of age 2. The patient is willing to comply with protocol-specified follow-up evaluations 3. The patient has been informed of the nature of the study, agrees to its provisions and has willingly provided written informed consent, approved by the appropriate Ethics Committee (EC) Cohort Specific Inclusion Criteria: Critical Limb Ischaemia Group Inclusion Criteria: 1. The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments. 2. Rutherford grade 4 or 5 critically ischemic foot, where the primary intention is to treat at least one occluded tibial vessel or 2 severely stenosed tibial vessels. Peripheral Arterial Disease Group Inclusion Criteria: 1. The subject is referred for a percutaneous peripheral revascularisation procedure on one of their lower limbs within 2 weeks of Baseline assessments. 2. This subject must have a clinical diagnosis of claudication and duplex or CT-confirmed SFA or popliteal artery stenoses greater than 70%, with no intention of primarily treating any tibial disease at this encounter. PAD-Free Group Inclusion Criteria: 1. The subject is recruited voluntarily 2. Absence of peripheral vascular disease determined by questionnaire and clinical review (triphasic signals on hand-held Doppler) Exclusion Criteria: 1. Infusion of vasoactive medications within the past 24 hours 2. The presence of a known chronic history of anaemia (i.e. Hb <8g/dL) 3. Congestive heart failure defined by NYHA Classification 3 or 4 4. The absence of intact skin at suitable measurement sites on the foot. 5. The presence of invasive soft tissue infection in the toes spreading into the forefoot. 6. The presence of physical impediment to the method of measurements being completed (i.e. absent first two toes, extensive ulceration, excessive oedema, pressure dressings or heavy bandaging, etc.) 7. The presence of a non-salvageable foot or a Rutherford 6 wound. 8. The presence of other conditions, which in the opinion of the Investigator, may compromise the subject safety or comfort. 9. The presence of other conditions, which in the opinion of the Investigator, may compromise the accuracy of the data obtained. 10. The patient is a vulnerable or protected adult, or is unable to provide consent. 11. The patient is unable to comply with the measurement protocol. 12. Pregnant subjects |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Addenbrooke's Hospital, Department of Vascular Surgery | Cambridge |
Lead Sponsor | Collaborator |
---|---|
Pedra Technology, PTE LTD |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Baseline safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in = 90% of subjects after removal of the Pedra sensors. | This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin). | Baseline visit: 30-60 minutes after pad removal | |
Primary | During procedure safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in = 90% of subjects after removal of the Pedra sensors. | This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin). | During procedure visit: 30-60 minutes after pad removal | |
Primary | 36-hrs post-procedure/ discharge visit safety endpoint: The absence of immediately observable skin reaction (rash; local oedema, blistering of the skin) in = 90% of subjects after removal of the Pedra sensors. | This observation assessment is completed by the physician post removal of the adhesive pads. It is either a "yes" or a "no" in observing if there is a skin reaction to the adhesive pads when they are removed from the skin and also documentation of what type of reaction (rash; local oedema, blistering of the skin). | 36-hrs post-procedure/ discharge visit: 30-60 minutes after pad removal |
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 |
NCT02384980 -
Saving Life and Limb: FES for the Elderly With PAD
|
Phase 1 |