Nctid:
NCT06222658
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D007511", "term"=>"Ischemia"}], "ancestors"=>[{"id"=>"D010335", "term"=>"Pathologic Processes"}], "browseLeaves"=>[{"id"=>"M10543", "name"=>"Ischemia", "asFound"=>"Ischemia", "relevance"=>"HIGH"}, {"id"=>"T170", "name"=>"Acute Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"NA", "maskingInfo"=>{"masking"=>"NONE"}, "primaryPurpose"=>"TREATMENT", "interventionModel"=>"SINGLE_GROUP"}, "enrollmentInfo"=>{"type"=>"ESTIMATED", "count"=>50}}, "statusModule"=>{"overallStatus"=>"RECRUITING", "startDateStruct"=>{"date"=>"2024-01-20", "type"=>"ESTIMATED"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2025-12-20", "type"=>"ESTIMATED"}, "lastUpdateSubmitDate"=>"2024-01-15", "studyFirstSubmitDate"=>"2023-09-26", "studyFirstSubmitQcDate"=>"2024-01-15", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2025-09-20", "type"=>"ESTIMATED"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Procedure success", "timeFrame"=>"immediately after angiography", "description"=>"completion of the endovascular procedure without the need for further intervention for revascularization and an absence of substantial or complete occlusion in any vessel at final angiography"}, {"measure"=>"Amputation-free survival", "timeFrame"=>"1 year", "description"=>"freedom from amputation to the treated limb or mortality at follow-up at 30 days, 6 months and 1 year"}]}, "oversightModule"=>{"isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Acute Limb Ischemia"]}, "referencesModule"=>{"references"=>[{"pmid"=>"32437952", "type"=>"BACKGROUND", "citation"=>"Ascher E, Kibrik P, Rizvi SA, Alsheekh A, Marks N, Hingorani A. Fast-track thrombolysis protocol for acute limb ischemia. J Vasc Surg. 2021 Mar;73(3):950-959. doi: 10.1016/j.jvs.2020.03.061. Epub 2020 May 11."}, {"pmid"=>"26109628", "type"=>"BACKGROUND", "citation"=>"Leung DA, Blitz LR, Nelson T, Amin A, Soukas PA, Nanjundappa A, Garcia MJ, Lookstein R, Simoni EJ. Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry. J Endovasc Ther. 2015 Aug;22(4):546-57. doi: 10.1177/1526602815592849. Epub 2015 Jun 24."}], "seeAlsoLinks"=>[{"url"=>"https://pubmed.ncbi.nlm.nih.gov/26109628/", "label"=>"Rheolytic Pharmacomechanical Thrombectomy for the Management of Acute Limb Ischemia: Results From the PEARL Registry"}, {"url"=>"https://pubmed.ncbi.nlm.nih.gov/32437952/", "label"=>"Fast-track thrombolysis protocol for acute limb ischemia"}]}, "descriptionModule"=>{"briefSummary"=>"The goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk .", "detailedDescription"=>"Acute lower extremity arterial ischemia (ALLI) is a common emergency in vascular surgery that has a high risk of limb amputation and mortality .It is caused by the blockage of an arterial flow to an extremity, which can be either thrombotic or embolic . Timely diagnosis and proper treatment for ALI are critical as to save limb viability .\n\nTreatment options include surgical embolectomy, catheter-directed thrombolysis (CDT) , as well as pharmacochemical thrombectomy , Each of those approaches has its own disadvantages.\n\nFogarty manoeuvre embolectomy although flexible technique that can be used in a variety of situation, it is an open surgical procedure, carries the risk of complications such as bleeding and wound healing disorders. Additionally, it may impose a risk of arterial wall injury in the presence of underlying arterial lesions.\n\nWhile CDT avoids common surgical complication its advantages include high risk of thrombo-lytic bleeding, residual thrombosis and long operation time and hospital stay.\n\nAs to address those limitations previous research has shown that using PMT as a first-line treatment for ALI provides rapid reperfusion to the extremity, reduces procedure time, and has an low risk profile .\n\nThe AngioJet Thrombectomy System (Boston Scientific Corporation, Marlborough, MA, USA) is a rheolytic PMT device that utilizes pressurized saline jets to generate a localized low-pressure zone (Bernoulli principle that results in fragmentation of the thrombus at the distal tip of the catheter.\n\nThe saline jets also provide the driving force through which the macerated thrombus particles are removed from the lesion site through the catheter. Several studies have demonstrated the effectiveness of the AngioJet system .\n\nThe goal of our protocol is to re-establish patency in ALLI, by combining both balloon maceration of a thrombus and angiojet PMT thus decreasing complications associated with prolonged periods of thrombolytic exposure while avoid open surgical risk ."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Age ≥ 18 years\n* Symptom onset within 14 days for acute limb ischemia or within 30 days for subacute limb ischemia due to embolic or thrombotic occlusion of a native arteries, bypass graft, or arterial stent.\n\nRutherford category I, IIa or IIb\n\nExclusion Criteria:\n\n* ALLI secondary to dissections, vasculitis, and/or target vessel trauma\n* Pregnancy or positive pregnancy test\n* Rutherford category III Irreversible (neglected) limb ischemia\n* patients allergic to contrast agent,\n* serum creatine\\>300 mmol/L"}, "identificationModule"=>{"nctId"=>"NCT06222658", "briefTitle"=>"The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia", "organization"=>{"class"=>"OTHER", "fullName"=>"Assiut University"}, "officialTitle"=>"The Role of Pharmaco-mechanical Thrombectomy in Management of Acute Lower Extremity Arterial Ischemia", "orgStudyIdInfo"=>{"id"=>"PMT in acute limb ischemia"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Patient assigned to pharmacomechanichal thrombectomy", "interventionNames"=>["Device: pharmaco-mechanichal thrombectomy"]}], "interventions"=>[{"name"=>"pharmaco-mechanichal thrombectomy", "type"=>"DEVICE", "otherNames"=>["Angiojet thrombectomy catheter"], "description"=>"pharmaco-mechanichal thrombectomy in acute limb ischemia", "armGroupLabels"=>["Patient assigned to pharmacomechanichal thrombectomy"]}]}, "contactsLocationsModule"=>{"locations"=>[{"city"=>"Asyūţ", "status"=>"RECRUITING", "country"=>"Egypt", "facility"=>"Asyut University Hospital", "geoPoint"=>{"lat"=>27.18096, "lon"=>31.18368}}], "centralContacts"=>[{"name"=>"ahmed m rashed", "role"=>"CONTACT", "email"=>"ahmedrashed9933@gmail.com", "phone"=>"00201064252719"}]}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Assiut University", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"PRINCIPAL_INVESTIGATOR", "investigatorTitle"=>"dr", "investigatorFullName"=>"Ahmed Mohammed Rashed", "investigatorAffiliation"=>"Assiut University"}}}}
