The main objective is to investigate whether the additional use of IVUS leads to an increase in net lumen gain (NLG) when compared with standard angiography-guided endovascular treatment as measured during control IVUS after six weeks. Secondary…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is NLG following IVUS-guided intervention when compared
with angiography-guided intervention after six weeks.
Secondary outcome
Secondary endpoints include ALG and per-procedural complications such as
arterial dissections.
Background summary
Endovascular interventions of below-the-knee (BTK) arteries are vital for limb
salvage in patients with chronic limb threatening ischemia (CLTI).
Unfortunately, endovascular treatment of BTK arteries has dissapointing results
in terms of patency. One of the reasons may be insufficient imaging of these
diseased arteries during the procedure with fluoroscopy and angiography. As
angiography shows a longitudinal two-dimensional image of the artery, it is
only capable of showing the vessel lumen, thereby the choice of accurate
treatment method and balloon sizing are challenging. Furthermore, complications
such as dissections may go unnoticed on angiography. In contrast, intravascular
ultrasound (IVUS) shows a cross-sectional image of the target lesion and vessel
lumen with improved detection of complications. Combining both angiography and
IVUS gives a three-dimensional impression of the target lesion and artery. This
improved imaging may lead to more accurate endovascular intervention methods,
potentially resulting in an increase in acute lumen gain (ALG), an increase in
net lumen gain (NLG) and subsequently better outcomes. In addition, IVUS may
lead to improved detection of immediate post-procedure complications.
Study objective
The main objective is to investigate whether the additional use of IVUS leads
to an increase in net lumen gain (NLG) when compared with standard
angiography-guided endovascular treatment as measured during control IVUS after
six weeks. Secondary objectives are related to per-procedural complications.
Study design
Monocenter investigator-initiated single-blind randomized controlled trial.
Intervention
IVUS-guided endovascular intervention of BTK arteries.
Study burden and risks
During endovascular treatment, IVUS will be used in addition to angiography to
guide the endovascular intervention and measure the vessel diameter. The
insertion of an IVUS catheter has no specific risk of complications. Balloon
sizing with the aid of IVUS will most likely lead to the use of larger
balloons. These balloons may cause more severe dissections or perprocedural
pain. On the other hand, the potential increased ALG and NLG at six week may
lead to faster wound healing and decreased risk of lower limb amputation.
Koekoekslaan 1
Nieuwegein 3435CM
NL
Koekoekslaan 1
Nieuwegein 3435CM
NL
Listed location countries
Age
Inclusion criteria
* Age >18 years old;
* CLTI, defined as the presence of PAD in combination with rest pain, gangrene,
or a lower limb ulceration >2 weeks duration;
* Indication for BTK endovascular revascularization, as set by the
multidisciplinary team;
* De novo vascular target lesion;
* Written informed consent.
Exclusion criteria
* Target lesions with a length of <5 cm or >20 cm;
* Kawarada Type III pedal arch (no patent dorsalis pedis artery, no patent
plantar artery);
* Below-the-knee (BTK) critical limb ischemia (CLTI) based on acute thrombosis
or thrombo-emboli;
* Renal insufficiency with a glomerular filtration rate (GFR) of less than 15
ml/min but not on dialysis;
* Contrast allergy;
* Non-salvageable limbs due to extensive tissue necrosis or infection
(Rutherford classification of chronic limb ischemia 6 or WiFi classification
wound score 3);
* ASA-classification of IV or higher;
* Ejection fraction <30%;
* MAC score >2;
* Target lesions not amenable for endovascular treatment by operators* decision
after baseline angiography (Angio-1);
* Pregnancy.
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84441.100.23 |