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.
Exclusion Criteria:
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]
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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Arkansas Heart Hospital