Ignite Creation Date:
2025-12-25 @ 5:18 AM
Ignite Modification Date:
2025-12-26 @ 4:26 AM
Study NCT ID:
NCT04822727
Status:
WITHDRAWN
Last Update Posted:
2023-08-23
First Post:
2021-03-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}], 'ancestors': [{'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D016491', 'term': 'Peripheral Vascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}, 'targetDuration': '12 Months', 'patientRegistry': True}, 'statusModule': {'whyStopped': 'Sponsor did not pusue with the study', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2021-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-21', 'studyFirstSubmitDate': '2021-03-24', 'studyFirstSubmitQcDate': '2021-03-29', 'lastUpdatePostDateStruct': {'date': '2023-08-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Freedom from MACE (Major Adverse Clinical Events) and/or Device related events during the procedure', 'timeFrame': 'during procedure', 'description': 'MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)'}, {'measure': 'Technical success rate', 'timeFrame': 'during procedure', 'description': 'defined as successfully introduction and deployment of the Lokum L-Quest, and/or the Lokum Amplatz, and/or the Slider Hydrophilic Nitinol Guidewire, and/or the Optimus CoCr Stent, and/or the Optimus PFTE covered BE Stent, and/or the AltoSa-XL-PTA, and/or the AltoSa-XL-Gemini Balloon Catheter according to the respective IFU and without device related deficiencies.'}], 'secondaryOutcomes': [{'measure': 'For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from MACE post-procedure, after 6- and 12-months.', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'MACE defined as: Death, Myocardial Infarction, Stroke, Emergent surgical revascularization of the target vessel, repeat vascularization of the target vessel, bleeding complication requiring transfusion)'}, {'measure': "For the Optimus CoCr and Optimus-CVS PTFE-covered stent: Freedom from Device-related serious adverse events (SAE's) post-procedure, after 6- and 12-months", 'timeFrame': 'Through study completion, an average of 1 year', 'description': "Freedom from Device-Related serious adverse events (SAE's)"}, {'measure': 'Freedom from Target Lesion Revascularization post-procedure, at 6- and 12-months', 'timeFrame': 'Through study completion, an average of 1 year', 'description': 'Defined as freedom from a repeat intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Iliac Artery Disease', 'Peripheral Artery Disease']}, 'descriptionModule': {'briefSummary': 'This PMCF study is designed as prospective, multi-center study to collect real-life data.\n\nThe rationale of this study is to confirm and support the clinical safety and performance of the aforementioned products in 200 patients who will undergo an endovascular intervention within standard-of-care (SOC) where at least 1 of the following devices from AndraTec were used:\n\nThe LOKUM-Quest guidewire, The LOKUM AMPLATZ guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA balloon, the AltoSa-XL GEMINI PTA Balloon, the OPTIMUS CoCr Stent , the OPTIMUS-CVS PTFE-Covered stent.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with peripheral arterial disease, meeting the in/exclusion criteria and eligible for treatment with the AndraTec devices, according to the IFU of each device.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Corresponding to the CE-mark indications/contra-indications and according to the current medical guidelines for minimally invasive peripheral interventions.\n\nPatient is willing to comply with specified follow-up evaluations at the specified times for the duration of the study (depending on the used device during the procedure) Patient is \\>18 years old Patient understands the nature of the procedure and provides written informed consent, prior to enrolment in the study Patient is eligible for treatment with\n\n* the Lokum L-Quest guidewire\n* and/or the Lokum Amplatz guidewire\n* and/or the Slider Hydrophilic Nitinol Guidewire\n* and/or the AltoSa-XL PTA balloon\n* and/or the AltoSa-XL Gemini balloon catheter\n* and/or the Optimus-XL CoCr Bare Metal Stent\n* and/or the Optimus-XL CVS PTFE Covered Stent, as described in the IFU for each device.\n\nExclusion Criteria:\n\n* Application in coronary, cerebral arteries and central circulatory system\n* Known contraindication to peripheral arterial and visceral vasculature treatment - Anatomy or size of vessels that will not allow appropriate usage of the investigational devices, following IFU of the investigational devices.\n* Known contraindication and/or allergy to (a component of) an investigational device\n* Pregnant women and women with childbearing potential not taking adequate contraceptives or currently breastfeeding\n* Life expectancy of less than twelve months\n* Any planned surgical intervention/procedure within 30 days of the study procedure\n* Any patient considered to be hemodynamically unstable at onset of procedure\n* Patient is currently participating in another investigational drug or device study that has not completed the entire follow-up period.\n\nDevice-related exclusion criteria (not applicable for guidewire):\n\n* Known contraindications given in the IFU of Optimus CoCr and Optimus-CVS PTFE- Covered Balloon-Expandable Stent which includes treatment of renal arteries, aneurysms adjacent to site of stent implantation and neurovascular treatment\n* Known contraindications given in the IFU of AltoSa-XL-PTA and AltoSa-XL-Gemini Balloon catheter:\n\n * patients with a contraindication for anti-platelet/anti-coagulant therapy\n * patients with excessive vessel tortuosity\n * dilatation of in-stent restenosis and highly calcified stenosis\n * patients with perforated vessels evidenced by extravasation of contrast media\n * patients with a known hypersensitivity to nylon'}, 'identificationModule': {'nctId': 'NCT04822727', 'briefTitle': 'AndraTec PMCF Study : Investigating the AndraTec Guidewires,PTA Balloons and Stents in Iliac Disease.', 'organization': {'class': 'OTHER', 'fullName': 'FCRE (Foundation for Cardiovascular Research and Education)'}, 'officialTitle': 'A Prospective Physician-Initiated PMCF Study Investigating the Safety and Clinical Performance of the Lokum L-Quest Guidewire, the Lokum Amplatz Guidewire, the Slider Hydrophilic Nitinol Guidewire, the AltoSa-XL PTA Balloon, the AltoSa-XL Gemini Balloon Catheter, the Optimus XL CoCr Stent and the Optimus CVS PTFE Covered XL Stent for the Endovascular Intervention', 'orgStudyIdInfo': {'id': 'FCRE-201016'}}, 'armsInterventionsModule': {'interventions': [{'name': '1 or more AndraTec devices (see description for list of devices)', 'type': 'DEVICE', 'description': '1 or more AndraTec devices (Lokum L-Quest guidewire, Lokum Amplatz guidewire, Slider Hydrophilic Nitinol Guidewire, AltoSa-XL PTA Balloon, Alto-Sa-XL Gemini Balloon, Optimus-CoCr stent, Optimus-CVS PTFE covered stent)'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Giovanni Torsello, Prof. MD.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Foundation for Cardiovascular Research and Education'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dr. Sabrina Overhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Study Director', 'investigatorFullName': 'Dr. Sabrina Overhagen', 'investigatorAffiliation': 'FCRE (Foundation for Cardiovascular Research and Education)'}}}}