Optical Coherence Tomography Contribution Assessment in the Revascularization of Long Femoropopliteal Occlusive Lesions (TASC C and D): A Randomized Trial.
Angiography
Constriction, Pathologic
Endovascular Procedures
/ adverse effects
Femoral Artery
/ diagnostic imaging
France
Humans
Multicenter Studies as Topic
Peripheral Arterial Disease
/ diagnostic imaging
Popliteal Artery
/ diagnostic imaging
Predictive Value of Tests
Prospective Studies
Randomized Controlled Trials as Topic
Single-Blind Method
Time Factors
Tomography, Optical Coherence
Treatment Outcome
Vascular Patency
Journal
Annals of vascular surgery
ISSN: 1615-5947
Titre abrégé: Ann Vasc Surg
Pays: Netherlands
ID NLM: 8703941
Informations de publication
Date de publication:
Jan 2021
Jan 2021
Historique:
received:
06
05
2020
revised:
26
06
2020
accepted:
29
06
2020
pubmed:
8
7
2020
medline:
20
1
2021
entrez:
8
7
2020
Statut:
ppublish
Résumé
Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions. The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov. The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months. The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.
Sections du résumé
BACKGROUND
BACKGROUND
Endovascular treatment has become the first-line revascularization technique for femoropopliteal lesions. This technique lacks reliable and accurate morphological control of the arterial segment treated. Intraoperative 2-dimensional angiogram consumes iodinated contrast media and increases X-ray exposure; this subsequently provides no 3-dimensional information on the quality of the revascularization completed, what could explain some of the early and late failures of the technique. We evaluated whether intraoperative optical coherence tomography (OCT) control in addition to standard angiogram could improve the primary patency rate at 12 months in comparison to standard angiogram alone in patients with occlusive femoropopliteal lesions.
METHODS
METHODS
The tomography by optical coherence in femoral artery trial is a multicentric, prospective, randomized, controlled, and single-blind study including patients with long de novo occlusive femoropopliteal lesions. The randomization will be achieved in 2 balanced groups of patients after crossing successfully the lesion: group 1 with intraoperative OCT control in addition to standard angiogram and group 2 with standard angiogram alone. The randomization will be stratified by center. The protocol has been submitted and approved by a French ethic's committee under reference number CPP2019-12-098. The study has been registered under the reference number NCT04434586 on the Web site of clinicaltrials.gov.
RESULTS
RESULTS
The primary outcome of the study is the primary patency at 12 months. The number of patients who need to be treated is 166 (83 in each group) considering 5% of no workable data. Symptoms' improvement, target lesion revascularization, target vessel revascularization, quality-of-life questionnaires, cost utility, and cost effectiveness will be analyzed as secondary end-point variables at 12 months.
CONCLUSIONS
CONCLUSIONS
The present study is to evaluate the potential benefit for patients on the result of endovascular revascularization of long occlusive femoropopliteal lesion at 12 months when using intraoperative OCT control.
Identifiants
pubmed: 32634565
pii: S0890-5096(20)30563-X
doi: 10.1016/j.avsg.2020.06.061
pii:
doi:
Banques de données
ClinicalTrials.gov
['NCT04434586']
Types de publication
Clinical Trial Protocol
Journal Article
Langues
eng
Sous-ensembles de citation
IM
Pagination
362-369Informations de copyright
Copyright © 2020 Elsevier Inc. All rights reserved.