Stenting blocked aorto-iliac arteries to lower blood pressure
Impact of Endovascular Treatment of Aorto-iliac Disease on Systemic Hypertension A Pilot Study Impact of Aorto-Iliac Occlusive Disease Treatment on Blood Pressure
This pilot will try stenting chronic aorto-iliac occlusions in adults to see if opening these blockages lowers central blood pressure and related heart stress markers.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 1 site (Arnhem) |
| Trial ID | NCT07070583 on ClinicalTrials.gov |
What this trial studies
This is a prospective pilot interventional study enrolling adults with chronic infrarenal aortic and/or common iliac artery occlusions who have a clinical indication for revascularization. Participants will undergo stent placement in the aorto-iliac region and will have central blood pressure and NT-proBNP measured before and after the procedure with scheduled follow-up visits. The trial focuses on lesions >=30 mm in length and excludes acute occlusions, juxtarenal pathology, and embolic disease. Outcomes will characterize short-term changes in afterload and biomarkers of intracardiac pressure following revascularization.
Who should consider this trial
Good fit: Adults (>=18 years) with chronic infrarenal aortic and/or common iliac artery occlusions of total lesion length >=30 mm who need revascularization for chronic limb-threatening ischemia or disabling claudication and can give informed consent and adhere to follow-up are ideal candidates.
Not a fit: Patients with juxtarenal pathology (lesions <2 cm below the lowest renal artery), acute occlusions (e.g., acute Leriche syndrome), embolic disease, or hypertension unrelated to vascular obstruction are unlikely to benefit from this procedure in this context.
Why it matters
Potential benefit: If successful, stenting these aorto-iliac occlusions could lower central blood pressure and intracardiac afterload, potentially improving blood pressure control and reducing risk of heart failure events for affected patients.
How similar studies have performed: Prior reports and small series have shown blood pressure reductions after stenting in the descending aorta and some distal arterial beds, but prospective data specifically for aorto-iliac stenting are limited and this pilot aims to fill that gap.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥18 years * Singed informed consent * Chronic occlusion in the infrarenal aorta and/or one or both common iliac arteries * Total lesion length of ≥30mm * Clinical indication for treatment of the pathology (Chronic limb threatening ischemia or disabling intermittent claudication not responding to supervised exercise training) Exclusion Criteria: * Patient is unable to understand the study requirements and/ or is unwilling to adhere to the follow-up * Juxtarenal pathology (\<2cm below the lowest renal artery) * Acute occlusion of the target area (Acute Leriche Syndrome) * Embolic disease
Where this trial is running
Arnhem
- Rijnstate — Arnhem, Netherlands (Recruiting)
Study contacts
- Study coordinator: Michel Reijnen, prof.dr.
- Email: vascularsurgery@rijnstate.nl
- Phone: 0031 88 005 7282
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.