Using advanced imaging to improve treatment planning for leg artery disease
The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
This study is testing whether using advanced imaging technology can help doctors plan better treatments for patients with leg artery disease to reduce the chances of stent problems later on.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 25 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Rijnstate Hospital Academic / other |
| Locations | 1 site (Arnhem, Gelderland) |
| Trial ID | NCT05057637 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of optical coherence tomography (OCT) on the endovascular treatment planning for patients with femoropopliteal stenosis. It aims to enhance the accuracy of stent sizing and positioning by providing high-resolution images of the arterial wall, which may be missed by traditional digital subtraction angiography (DSA). By improving treatment planning, the study seeks to reduce the risk of stent failure and restenosis. Participants will undergo OCT measurements prior to their scheduled endovascular treatment.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older who are scheduled for endovascular treatment of femoropopliteal stenotic lesions.
Not a fit: Patients with occluded arteries, severely impaired renal function, or those participating in other conflicting trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and reduced complications for patients with femoropopliteal disease.
How similar studies have performed: While the use of OCT in vascular imaging is established, this specific application in femoropopliteal disease treatment planning is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 years of older * Written informed consent * Scheduled endovascular treatment of femoropopliteal stenotic lesions with a Supera interwoven nitinol stent or Absolute nitinol stent * Clinically and hemodynamically stable Exclusion Criteria: * Occluded superficial femoral artery or popliteal artery * Superficial femoral artery and/or popliteal artery diameter larger than 6.5 mm * Severely impaired renal function (eGFR \< 30 ml/min), end stage renal disease * Cardiac insufficiency (NYHA 3-4) * Hypersensitivity to iodinated contrast media * BMI \> 25 and contralateral approach not possible * Minimal lumen diameter of target lesion \< 1.5 mm * Presence of a hemodynamically significant inflow stenosis in the aorto-iliac tract or the common femoral artery * Participating in another trial with an investigational drug or medical device concerning the femoropopliteal tract interfering with the current study * Life expectancy of less than 24 months * Women of child-bearing age not on active birth control * Legally incapable
Where this trial is running
Arnhem, Gelderland
- Rijnstate — Arnhem, Gelderland, Netherlands (Recruiting)
Study contacts
- Principal investigator: Michel Reijnen, MD, prof — Rijnstate Hospital
- Study coordinator: Michel Reijnen, MD, prof
- Email: MReijnen@rijnstate.nl
- Phone: 0880057282
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.