Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-03-24 @ 2:10 AM
Study NCT ID:
NCT02033135
Status:
UNKNOWN
Last Update Posted:
2014-01-10
First Post:
2014-01-08
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058729', 'term': 'Peripheral Arterial Disease'}, {'id': 'D050197', 'term': 'Atherosclerosis'}, {'id': 'D007383', 'term': 'Intermittent Claudication'}], 'ancestors': [{'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'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D017130', 'term': 'Angioplasty'}], 'ancestors': [{'id': 'D002404', 'term': 'Catheterization'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D057510', 'term': 'Endovascular Procedures'}, {'id': 'D014656', 'term': 'Vascular Surgical Procedures'}, {'id': 'D013504', 'term': 'Cardiovascular Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D019060', 'term': 'Minimally Invasive Surgical Procedures'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 84}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-01', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2014-01-09', 'studyFirstSubmitDate': '2014-01-08', 'studyFirstSubmitQcDate': '2014-01-09', 'lastUpdatePostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-01-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximal walking distance', 'timeFrame': '24 months', 'description': 'Walking distance will be quantified by standardized treadmill testing using constant speed of 3 km per hour with no incline for a maximum of 5 minutes.'}], 'secondaryOutcomes': [{'measure': 'Ankle brachial pressure indices', 'timeFrame': '24 months', 'description': 'a measure of the peripheral bloodpressure'}, {'measure': 'Quality of life', 'timeFrame': '24 months', 'description': 'Quality of life is evaluated by using questionnaires'}, {'measure': 'Cost of the treatment', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Atherosclerosis', 'Intermittent claudication', 'Angioplasty'], 'conditions': ['Peripheral Arterial Disease']}, 'descriptionModule': {'briefSummary': 'This randomized clinical study is intended to evaluate the use of Zilver PTX stents for treatment of thigh atherosclerosis.\n\nResearch question: Is there an adjuvant benefit of angioplasty and stenting using the new paclitaxel eluting stent, Zilver-PTX, over risk factor modification and medical therapy alone in patients with stable, mild to moderate intermittent claudication caused by femoropopliteal lesions suitable for endovascular management.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patient has signed and dated the informed consent.\n* Patient has 1- 2 documented stenotic or occluded atherosclerotic lesions (up to 18 cm long) of the above-the-knee femoropopliteal artery, that meet all of the inclusion criteria and none of the exclusion criteria.\n* Reference vessel (the above-the-knee femoropopliteal artery) diameter of 4 mm to 9 mm.\n* Taget lesion(s) should be accessible for stenting, as imaged with angiography (digital subtraction, MRI or CTI), i.e. proximal cm of SFA must be open\n* Patient has a de novo or restenotic lesion(s) with \\>50% stenosis documented angiographically and no prior stent in the target lesion.\n* Patient has symptoms of peripheral arterial disease classified as Rutherford Category 2 (moderate claudication) or 3 (severe claudication) lasting for at least 3 months. (Positive Claudication Questionnaire)\n* Exercise therapy, smoking cessation advise and best medical therapy must have been implemented at least 3 months ago and without significant clinical effect.\n* Patient has a resting ABI \\<0.9 or an abnormal exercise ABI (decrease of more than 0.15) if resting ABI is normal. Patient with incompressible arteries (ABI \\>1.2) must have a TBI \\<0.8.\n* Patient agrees to return for a clinical status assessment and duplex ultrasound at 6 weeks, 6 months, 12 months, and at 24 months.\n\nExclusion Criteria:\n\n* Patient is pregnant, breast-feeding or under 18 years of age.\n* Patient unable to understand and sign informed consent forms\n* Patient is simultaneously participating in another investigational drug or device study.\n* Patient has any planned surgical or interventional procedure within 30 days after the study procedure.\n* Patient in whom antiplatelet and/or anticoagulant therapy is contraindicated.\n* Patient has known hypersensitivity or contraindication to aspirin, antiplatelet medication, contrast dye, paclitaxel or nitinol.\n* Patient 2-3 patent crural vessel runoff with \\<50% stenosis throughout its course.\n* Activity limited by co-morbid condition other than claudication, for example: severe coronary artery disease; angina pectoris; chronic lung disease; neurological disorder such as hemiparesis; arthritis, or other musculoskeletal conditions including amputation and BMI \\> 40\n* Other active significant medical problems such as cancer, known chronic renal disease (serum creatinine greater than 2.0 mg/dl within 60 days or renal replacement therapy), known chronic liver disease or anaemia, active substance abuse, or known history of dementia'}, 'identificationModule': {'nctId': 'NCT02033135', 'acronym': 'PESETA', 'briefTitle': 'Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Paclitaxel Eluting Stent or Exercise for Thigh Atherosclerosis (PESETA)', 'orgStudyIdInfo': {'id': 'H 4 2012 027'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Angioplasty with Zilver PTX', 'description': 'Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX) plus unsupervised exercise therapy, smoking cessation advice and best medical therapy.', 'interventionNames': ['Procedure: Angioplasty with Zilver PTX', 'Other: Best medical treatment', 'Device: Zilver PTX']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Best medical treatment', 'description': 'Unsupervised exercise therapy, smoking cessation advice and best medical therapy.', 'interventionNames': ['Other: Best medical treatment']}], 'interventions': [{'name': 'Angioplasty with Zilver PTX', 'type': 'PROCEDURE', 'description': 'Angioplasty and stenting with a polymer free paclitaxel-eluting stent (Zilver-PTX)', 'armGroupLabels': ['Angioplasty with Zilver PTX']}, {'name': 'Best medical treatment', 'type': 'OTHER', 'description': 'Treatment with antiplatelet and statins, smoking cessation advice and unsupervised walking exercise.', 'armGroupLabels': ['Angioplasty with Zilver PTX', 'Best medical treatment']}, {'name': 'Zilver PTX', 'type': 'DEVICE', 'armGroupLabels': ['Angioplasty with Zilver PTX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2100', 'city': 'Copenhagen', 'state': 'Østerbro', 'status': 'RECRUITING', 'country': 'Denmark', 'contacts': [{'name': 'Lise Pyndt, MD', 'role': 'CONTACT', 'email': 'lpyndt@gmail.com', 'phone': '+45 35457458'}, {'name': 'Lise Pyndt, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}], 'centralContacts': [{'name': 'Lise P Jørgensen, MD,', 'role': 'CONTACT', 'email': 'lpyndt@gmail.com', 'phone': '+45 3545 3654'}, {'name': 'Torben V Schroeder, MD, MDSc', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Torben V Schroeder, MD, MDSc', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Dept. of Vasc. Surg., Rigshospitalet, Blegdamsvej 9, 2100 KBH Ø, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, Ph. D. student', 'investigatorFullName': 'Lise Pyndt Jørgensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}