A Phase 4 interventional study of Percutaneous Peripheral Intervention and Optical Coherence Tomography in Peripheral Arterial Disease, sponsored by Arkansas Heart Hospital. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-01-11.
Sponsored by Arkansas Heart Hospital · Phase 4, Interventional, and Treatment
This is an interventional study assessing the effectiveness of Ticagrelor on the reduction of thrombus burden using optical coherence tomography in patients undergoing peripheral artery stenting.
Prospective, randomized study, comparing ticagrelor + aspirin vs. aspirin monotherapy following the 4-week post-procedural combination of Ticagrelor or Plavix with low dose aspirin. The investigators will enroll a minimum of 40 patients. Patients will be enrolled if they have either claudication and/or critical limb ischemia, and angiographically identified superficial femoral artery (SFA) disease requiring intervention, with either total occlusion or a significant SFA stenosis with the presence of Optical Coherence Tomography (OCT) defined clot following stent placement.
Participants will be evaluated at baseline, 1 month, 4 months, 6 and 7 months following SFA intervention. At baseline demographic data will be collected, and anthropomorphic and physiological variables (body mass index, waist circumference, blood pressure). Baseline and 6-month ankle brachial index (ABI) will be performed. A 6-min walk test will be performed at baseline and 6-month follow-up. At 6 month time point patients in both treatment groups will return for a peripheral angiogram and repeat OCT imaging of the SFA segments of interest. Subject will have a final follow up clinic visit at 7 months.
1,377 studies on the registry are indexed under Peripheral Arterial Disease; 275 are open to participants now.
This study's enrollment of 26 is below the median of 70 across 927 interventional studies indexed under Peripheral Arterial Disease.
Browse Peripheral Arterial Disease studies →Arkansas Heart Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clopidogrel 75 mg + aspirin 81 mg for the first month followed by aspirin 81 mg alone for months 2-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT) ankle brachial index (ABI) and six minute walk distance.
Procedure: Percutaneous Peripheral Intervention · Device: Optical Coherence Tomography · Other: Ankle Brachial Index · Other: Six minute walk distance · Drug: Aspirin
ticagrelor 90 mg bid + aspirin 81 mg for months 1-6 months post percutaneous peripheral intervention (PPI) intervention assessed by optical coherence tomography (OCT)ankle brachial index (ABI) and six minute walk distance.
Procedure: Percutaneous Peripheral Intervention · Device: Optical Coherence Tomography · Other: Ankle Brachial Index · Other: Six minute walk distance · Drug: Aspirin + Ticagrelor
Percutaneous peripheral intervention is a common procedure performed by cardiologists to revascularize peripheral arterial lesions in patients (stent placement). This procedure is considered standard of care and is not experimental.
This is an established medical imaging technique that uses light to capture micrometer-resolution, three-dimensional images from within optical scattering media. The device used is a cardiac catheter with OCT sensors on the tip of it. It will be used to assess the artery vessels after Percutaneous Peripheral Intervention.
This a clinical assessment and consists of the calculation of the ratio of the blood pressure in the lower legs to the blood pressure in the arms. The ABI is calculated by dividing the systolic blood pressure at the ankle by the systolic blood pressures in the arm.
Assessment of the walking distance in 6 minutes.
Aspirin, also known as acetylsalicylic acid \[ASA\], is a salicylate drug, often used as an analgesic to relieve minor aches and pains, as an antipyretic to reduce fever, and as an anti-inflammatory medication. Aspirin also has an antiplatelet effect by inhibiting the production of thromboxane, which under normal circumstances binds platelet molecules together to create a patch over damaged walls of blood vessels.
Also known as: Acetylsalicylic acid [ASA]
Drug pages: Aspirin · Ticagrelor
This is a combination of drugs (Aspirin + Ticagrelor). Ticagrelor is a platelet aggregation inhibitor due to its properties as an antagonist of the P2Y12 receptor. Ticagrelor is a nucleoside analogue: the cyclopentane ring is similar to the sugar ribose, and the nitrogen rich aromatic ring system resembles the nucleobase purine, giving the molecule an overall similarity to adenosine.
Also known as: acetylsalicylic acid [ASA] + Brillinta
Change in the Intraluminal clot volume (in mm3)
Intraluminal clot volume will be assessed by Optical Coherence Tomography using a Core Lab.
Time frame: At baseline and at 6 months
Change in the Intraluminal clot length (mm)
Intraluminal clotlength will be assessed by Optical Coherence Tomography using a Core Lab.
Time frame: At baseline and at 6 months
This study is terminated, as verified in Jan 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drugs tested here: Aspirin · Ticagrelor
Arkansas Heart Hospital