Ignite Creation Date:
2025-12-25 @ 12:12 AM
Ignite Modification Date:
2026-02-20 @ 6:39 PM
Study NCT ID:
NCT03111758
Status:
TERMINATED
Last Update Posted:
2022-03-04
First Post:
2017-04-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Flow Augmentation Study in Postthrombotic Patients
Sponsor:
Maastricht University Medical Center
Organization:
Study Overview
Official Title:
Flow Augmentation With Geko Device in Patients With Postthrombotic Syndrome a Prospective Randomised Cross-Over Trial
Status:
TERMINATED
Status Verified Date:
2022-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Reaching total sample size was not feasible within the anticipated time frame.
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Rationale:
Stent therapy has been proven to be an effective form of therapy in the treatment of chronic iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow. This will inherently prevent early stent occlusion. Our aim is to investigate whether the Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients during the first day after stenting.
Objective: The primary objective of this study is to identify whether the Geko system is effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting.
Study design: Interventional pilot study with randomized cross-sectional design.
Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous procedure (PTA, stenting).
Intervention (if applicable): Treatment with intermittent pneumatic compression stockings (IPCS) and Geko-device.
Main study parameters/endpoints: The main endpoint and parameter of this study is time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its pulse wave Doppler function.
Stent therapy has been proven to be an effective form of therapy in the treatment of chronic iliofemoral and iliocaval post-thrombotic obstruction. During the first post-intervention day intermittent pneumatic compression stockings (IPCS) are necessary to augment venous flow. This will inherently prevent early stent occlusion. Our aim is to investigate whether the Geko device is effective as IPCS regarding augmentation of flow in post-thrombotic patients during the first day after stenting.
Objective: The primary objective of this study is to identify whether the Geko system is effective in augmenting flow compared to IPCS in post-thrombotic limbs before after stenting.
Study design: Interventional pilot study with randomized cross-sectional design.
Study population: Patients with a post-thrombotic obstruction undergoing a percutaneous procedure (PTA, stenting).
Intervention (if applicable): Treatment with intermittent pneumatic compression stockings (IPCS) and Geko-device.
Main study parameters/endpoints: The main endpoint and parameter of this study is time-averaged maximum flow velocity (TAMFV), measured by duplex ultrasonography using its pulse wave Doppler function.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: