Clinical Implications of Peripheral Plaque Morphology

• Status: Unknown status
• Trial end date: 0000-00-00
• Target enrollment: 143
• Participant gender: Both

Summary

Peripheral Artery Disease involves a buildup of fatty deposits (plaque) within blood vessels that can restrict blood flow. Patients who have PAD and claudication (pain in legs during exercise due to poor blood circulation) may be eligible for this clinical trial. Three primary hypotheses will be tested in this study: (1) IVUS (Intravascular Ultrasound)combined with advanced digital image and signal processing provides a sensitive method to determine plaque geometry and composition in the human peripheral artery wall; (2) IVUS can discern specific arterial wall morphology, providing data that can be used to identify plaques that predispose the patient to late complications; and (3) IVUS-derived plaque structure can be used to predict responders and non-responders to pharmacologic therapy and percutaneous endovascular interventions. These hypotheses will be tested as follows: (1) custom engineered IVUS analysis software will be used to describe the geometry, composition, and spatial component relationships of the vessel, (2) the morphology of lower extremity arterial plaque, as determined by IVUS, will be correlated with baseline clinical characteristics of subjects, and (3) the effects on plaque morphology after long term treatment with antihyperlipidemics will be determined.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Atorvastatin Calcium
• Last Updated: 2013-05-02

Criteria

Inclusion Criteria:

1. Age ≥18 years.

2. Symptoms of intermittent claudication, rest pain, or minor tissue loss (Rutherford Category I - V).99

3. Non invasive laboratory evidence of peripheral vascular disease.

4. Angiographic demonstration of a 100 mm patent segment of a lower extremity artery containing at least one visually estimated stenosis of 20 - 80% diameter reduction.

Exclusion Criteria:

1. Acute limb ischemia, defined by a significant change in symptoms (one category on the Rutherford scale99 within the previous 14 days).

2. Concurrent oral anticoagulant therapy that cannot be safely withheld.

3. Extensive tissue loss and/or gangrene which would result in an above knee or below knee amputation(s).