Ignite Creation Date:
2024-05-06 @ 4:40 PM
Last Modification Date:
2024-10-26 @ 2:14 PM
Study NCT ID:
NCT05057637
Status:
RECRUITING
Last Update Posted:
2023-08-02
First Post:
2021-09-01
Brief Title:
The Impact of Optical Coherence Tomography on the Endovascular Treatment Planning of Femoropopliteal Disease
Sponsor:
Rijnstate Hospital
Organization:
Rijnstate Hospital
Study Overview
Official Title:
The Impact of Optical Coherence Tomography on the Decision-making Process of Endovascular Treatment of Femoropopliteal Disease
Status:
RECRUITING
Status Verified Date:
2023-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Optimo
Brief Summary:
Rationale Peripheral arterial disease is a severe clinical problem with an increasing prevalence due to an ageing population Endovascular treatment usually using stents is recommended for most lesions in the femoropopliteal tract The patency of these stents is influenced by several factors including stent sizing and stent positioning
Current procedural planning of femoropopliteal disease is primarily based on single-plane digital subtraction angiographies DSA This modality provides a 2-dimensional image of the vessel lumen which may be suboptimal for stent sizing It can therefore be difficult to choose the optimal stent position as minor lesions may be missed Suboptimal treatment could result in unfavourable levels of wall shear stress causing the vessel wall to be more susceptible to neo-intimal hyperplasia ultimately causing restenosis and stent failure Intravascular optical coherence tomography OCT is able to visualize the arterial wall with a micrometer resolution which could result in better stent sizing Furthermore OCT is able to visualize different layers in the vessel wall and identify unhealthy areas which may lead to a more optimal stent placement as unhealthy areas can be covered completely Moreover OCT provides detailed patient-specific geometries necessary to develop reliable computational fluid dynamics CFD models that simulate blood flow in stented arteries and calculate wall shear stresses which could predict stent patency
Objective To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement in comparison to traditional digital subtraction angiography-based treatment planning
Study design Exploratory observational study Study population 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent
Main study parametersendpoints The percentage of procedures in which OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning
Current procedural planning of femoropopliteal disease is primarily based on single-plane digital subtraction angiographies DSA This modality provides a 2-dimensional image of the vessel lumen which may be suboptimal for stent sizing It can therefore be difficult to choose the optimal stent position as minor lesions may be missed Suboptimal treatment could result in unfavourable levels of wall shear stress causing the vessel wall to be more susceptible to neo-intimal hyperplasia ultimately causing restenosis and stent failure Intravascular optical coherence tomography OCT is able to visualize the arterial wall with a micrometer resolution which could result in better stent sizing Furthermore OCT is able to visualize different layers in the vessel wall and identify unhealthy areas which may lead to a more optimal stent placement as unhealthy areas can be covered completely Moreover OCT provides detailed patient-specific geometries necessary to develop reliable computational fluid dynamics CFD models that simulate blood flow in stented arteries and calculate wall shear stresses which could predict stent patency
Objective To investigate in a clinical study how often the use of intravascular optical coherence tomography for femoropopliteal stenotic lesions leads to alterations in treatment planning before and after stent placement in comparison to traditional digital subtraction angiography-based treatment planning
Study design Exploratory observational study Study population 25 patients with femoropopliteal stenotic lesions who are treated with a Supera interwoven nitinol stent or Absolute nitinol stent
Main study parametersendpoints The percentage of procedures in which OCT changed the DSA-based treatment planning before and after stent placement to investigate the impact of OCT imaging on treatment planning
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None