None listed
Conditions
Brief summary
Peripheral arterial diseases (PADs) are a collection of chronic occlusive conditions affecting adults, which predominately occur due to atherosclerosis and affects approximately 15% of the Australian population. Lipoprotein (a) [Lp(a)] is an emerging risk factor for PAD and atherosclerosis. Multiple studies have demonstrated a causal relationship between elevated Lp(a) and the development of atherosclerotic cardiovascular disease, calcific aortic valve disease and inflammation. The role of Lp(a) in restenosis in PAD is unclear, however Lp(a) is implicated in promoting atherosclerosis progression, thrombosis and inflammation which are all pathological processes thought to be critical in stimulating PAD progression and the need for surgical intervention. The primary aim of this study is to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy.
Interventions
This is an interventional, prospective study to assess the relationship between serum Lp(a) concentration and the development of restenosis in 60 patients with aortoiliac PAD undergoing endovascular therapy up to 12 months post endovascular therapy. The patient's procedure will be conducted as per usual standard of care. Blood sample will be collected at baseline, post-procedure and 1-, 6- and 12-months post-procedure.
Sponsors
Royal Perth Hospital
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patients greater than or equal to 18 years of age 2. The participant has provided written informed consent 3. Evidence of TASC B, C or D lesions (TASC II classification) 4. Patients undergoing endovascular therapy for aortoiliac occlusive disease
Exclusion criteria
1. Patients less than 18 years of age 2. Pregnant women or women of childbearing potential who are not using an effective method of contraception 3. Uncontrolled hypertension 4. TASC A lesion 5. Patients requiring open procedure 6. Extensive common femoral artery disease or multiple groin procedures 7. Contraindication to antiplatelet use 8. Occluded superficial and profunda femoral arteries 9. Noncompliance with protocol requirements 10. Previous or planned surgical or interventional procedure within 14 days before or 30 days after the index procedure
Outcome results
None listed