Werkzaamheid en veiligheid van LOBO™ vasculair occlusieapparaat voor embolisatie van pulmonale arterioveneuze malformaties (PAVM)
Werkzaamheid en veiligheid van LOBO™ vasculair occlusieapparaat voor embolisatie van pulmonale arterioveneuze malformaties (PAVM)
The goal of this clinical trial is to evaluate both the technical success and efficacy of using the LOBO™ device in patients undergoing embolization of Pulmonary Arteriovenous Malformations (PAVM). The main question[s] it aims to answer [is/are]:
- What is the technical success rate, the number of LOBO™ devices needed for occlusion, and time to occlusion for each feeding artery during PAVM embolization using the LOBO™ device?
- What is the short-term occlusion rate of the LOBO™ device for PAVM embolization (6 months post-embolization)?
- What are the medium- and long-term occlusion rate of the LOBO™ device in PAVMs (12 months and 36 months post embolization)?
Researchers will compare the percentage of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to percentage of conventionally embolized PAVMs that develop recanalization at the same intervals.
Participants will undergo the embolization procedure and be followed for 36 months after the procedure. There will be a total of 4 study visits:
- Treatment visit
- 6-Month Follow-up visit
- 12-Month Follow-up visit
- 36-Month Follow-up visit
At each clinical follow-up visit participants will undergo imaging with a computed tomography angiography (CTA) of the chest.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
This is a prospective, interventional, single-center investigation involving the enrollment of 30 participants with PAVMs with feeding arteries ≥2 mm in diameter. Per standard of care and current clinical practice at UNC, all patients are first evaluated at the UNC Hereditary Hemorrhagic Telangiectasia (HHT) clinic which is run by the UNC Hematology Division. Based on clinical symptoms and signs (shortness of breath, hypoxia, positive bubble study, history of stroke or transient ischemic attack), and/or imaging findings (i.e., feeding artery size) on chest computed tomography angiography (CTA), patients are referred to interventional radiology for consultation for PAVM embolization. At this time, patients will be approached for enrollment in this study. This study aims to assess the technical success and rates of recanalization of PAVMs embolized using the LOBO™ device.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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North Carolina
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Chapel Hill, North Carolina, Verenigde Staten, 27599
- University of North Carolina at Chapel Hill
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- At least 1 PAVM with a feeding artery ≥2 mm in diameter and a feeding artery amenable to the use of LOBO™ device (i.e. feeding artery length of ≥1 cm). Given the length of embolic devices including LOBO™, the proximal vessel length to the PAVM sac must be of sufficient size for embolization to be feasible. If patients have at least 1 PAVM where the feeding artery length is ≥1 cm, they are eligible for enrollment.
- Patients with multiple PAVMs meeting eligibility criteria may be enrolled with the intent of embolizing multiple different PAVMs with the LOBO™ device in the same embolization session or in separate sessions.
- Estimated Glomerular Filtration Rate >30 ml/min
- Per standard of care (SOC), all pregnant women to be enrolled must be in their 2nd or 3rd trimesters
Exclusion Criteria:
- Confounding bleeding disorders other than HHT
- Life-threatening iodinated contrast allergy not amenable to prophylactic therapy with steroids
- Underlying coagulopathy
- Patients on anti-platelets or anti-coagulation medications
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Ander: PAVM Embolization
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. |
This study consists of one group. All participants will undergo PAVM embolization with a LOBO™ device. Participants will undergo PAVM embolization with the LOBO™ device per standard of care. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Proportion of Technical Success
Tijdsspanne: At treatment until stasis is achieved. Approximately 1 - 2 hours.
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Technical success will be defined as the successful deployment of the LOBO™ device in the intended vessel and complete occlusion of the vessel. Successful deployment will be defined as 1) no technical malfunctions in the LOBO™ deployment system that leads to an inability to deploy the device and 2) deployment of the device into the intended vessel and not into surrounding vessels. Complete occlusion will be defined as complete cessation of blood flow through the embolized vessel based on intraprocedural angiography. |
At treatment until stasis is achieved. Approximately 1 - 2 hours.
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean Number of LOBO Plugs
Tijdsspanne: At treatment until stasis is achieved. Approx. 1 - 2 hours.
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Descriptive statistics for the number of LOBO™ devices needed for technical success will be reported. |
At treatment until stasis is achieved. Approx. 1 - 2 hours.
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Mean Time to Complete Occlusion
Tijdsspanne: At treatment until stasis is achieved. Approx. 1 - 2 hours.
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Descriptive statistics for the time to completion will be reported. |
At treatment until stasis is achieved. Approx. 1 - 2 hours.
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Short-term Occlusion Rate
Tijdsspanne: 6 months post-embolization
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Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred. |
6 months post-embolization
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Medium- and Long-term Occlusion Rates
Tijdsspanne: 12 months and 36 months post-embolization
|
Recanalization will be defined as contrast visualization through the plug or the aneurysmal sac on follow-up CTA's. Interpretation of these images will be done by standard clinical radiologists and not research personnel. The reading radiologist's interpretation will be used to determine if recanalization has occurred. |
12 months and 36 months post-embolization
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Recanalization Rates by Modality (LOBO vs conventional)
Tijdsspanne: 6, 12, and 36-months post-embolization
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Proportion of LOBO™ embolized PAVMs that develop recanalization at 6, 12, and 36- month intervals compared to proportion of conventionally embolized PAVMs (those embolized with coils, Amplatzer, MVPs) that develop recanalization at the same intervals. The retrospective comparator group will consist of patients who have undergone conventional embolization at UNC in a separate trial. |
6, 12, and 36-months post-embolization
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Medewerkers en onderzoekers
Medewerkers
Onderzoekers
- Hoofdonderzoeker: Nima Kokabi, MD, University of North Carolina, Chapel Hill
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- 24-2233
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
IPD-tijdsbestek voor delen
Beginning 9 and continuing for 36 months following publication.
IPD-toegangscriteria voor delen
Investigator has approved IRB, IEC, or REB and an executed data use/sharing agreement with UNC.
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
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