- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02110524
CVI Drug Coated Balloon First In Human Trial
Prospective, Controlled, Multi-Center, Open, Single Arm Study for the Treatment of Subjects Presenting De Novo Occluded/Stenotic or Re-occluded/Restenotic Lesions of the Superficial Femoral or Popliteal Arteries Using a Paclitaxel-Coated Percutaneous Angioplasty Catheter
The purpose of this study is to assess safety and the inhibition of restenosis of the CVI Paclitaxel-coated PTA Balloon Catheter in the treatment of de-novo occluded/stenotic or reoccluded/restenotic superficial femoral (SFA) or popliteal arteries.
The primary endpoint for this analysis is late lumen loss at six (6) months.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Prospective, controlled, multi-center, open, single arm study
Main cohort: 50; pre-specified treatment group: 30. Total patients: 80
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Berlin, Germany, 13347
- Jewish Hospital Berlin
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Subjects with symptomatic leg ischemia, requiring treatment of SFA or popliteal (P1 segment) artery
- De novo or restenotic lesion(s) >70% within the SFA and popliteal arteries in a single limb which are ≥3 cm and ≤15 cm in cumulative total length (by visual estimation).
- Target vessel reference diameter ≥3 mm and ≤7 mm (by visual estimation).
- Rutherford classification of 2, 3 or 4
Exclusion Criteria:
- Lesion length is <3 cm or >15 cm or there is no normal proximal arterial segment in which duplex ultrasound velocity ratios can be measured.
- Outflow arteries (distal popliteal, anterior or posterior tibial or peroneal arteries) with significant lesions (≥ 50% stenosis) may not be treated during the same procedure.
- Treatment of the contralateral limb during the same procedure or within 30 days of the study procedure.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: CVI Drug Coated Balloon
|
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Primary endpoint: Angiographic late lumen loss
Time Frame: 6Month
|
difference between minimum lumen diameter after intervention and follow up.
|
6Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Secondary safety endpoint: Major Adverse Event (MAE) rate
Time Frame: 6Months
|
composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).
|
6Months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Henrik Schröder, MD, Jewish Hospital Berlin
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Arteriosclerosis
- Arterial Occlusive Diseases
- Atherosclerosis
- Peripheral Arterial Disease
- Peripheral Vascular Diseases
- Molecular Mechanisms of Pharmacological Action
- Antineoplastic Agents
- Tubulin Modulators
- Antimitotic Agents
- Mitosis Modulators
- Antineoplastic Agents, Phytogenic
- Paclitaxel
Other Study ID Numbers
- TP1027
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Peripheral Arterial Disease
-
University of NebraskaNot yet recruitingPeripheral Arterial Disease | Peripheral Vascular Diseases | Peripheral Arterial Occlusive Disease | Peripheral Artery DiseaseUnited States
-
CID S.p.A.Meditrial Europe Ltd.Not yet recruitingPeripheral Arterial Occlusive Disease | Peripheral Artery DiseaseItaly
-
Marissa JarosinskiRecruitingPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery Disease | Clopidogrel, Poor Metabolism of | Artery DiseaseUnited States
-
Stanford UniversityTerminatedPAD - Peripheral Arterial Disease | PVD- Peripheral Vascular DiseaseUnited States
-
Vascuros Medical Pte LtdNovella ClinicalUnknownPeripheral Arterial Occlusive Disease | Peripheral Vascular Disease | Peripheral Artery DiseaseSingapore, Belgium, Germany
-
Western Vascular Institute, IrelandRecruitingPeripheral Arterial Occlusive DiseaseIreland
-
Jena University HospitalAngioDroid s.r.l., Bologna (Italy)CompletedPeripheral Arterial Occlusive DiseaseGermany
-
Seoul National University HospitalAstellas Pharma Korea, Inc.CompletedPeripheral Arterial Occlusive DiseaseKorea, Republic of
-
Heidelberg UniversityTerminatedPeripheral Arterial Occlusive DiseaseGermany
-
Johann Wolfgang Goethe University HospitalSuspendedPeripheral Arterial Occlusive DiseaseGermany
Clinical Trials on Percutaneous Transluminal Angioplasty
-
National Heart, Lung, and Blood Institute (NHLBI)CompletedStructural Heart Disease | Obstructive Coronary Artery Disease | Obstructive Peripheral Artery DiseaseUnited States
-
Third Military Medical UniversityUnknown
-
Heinrich-Heine University, DuesseldorfGerman Diabetes CenterRecruitingDiabetes Mellitus | Diabetic Foot | Diabetic Neuropathies | Peripheral Arterial Disease | Anemia | Diabetic Retinopathy | Diabetic Polyneuropathy | Ulcer Foot | Ulcer IschemicGermany
-
ArthesysCompleted
-
Fundació Institut de Recerca de l'Hospital de la...Unknown
-
University of CreteCompletedIschemic Foot Ulcers
-
Contego Medical, Inc.CompletedPeripheral Arterial Disease | Intermittent Claudication | Atherosclerosis of Femoral ArteryBelgium, Germany
-
Chinese Pulmonary Vascular Disease Research GroupRecruitingTakayasu Arteritis With Pulmonary Artery Involvement | Percutaneous Transluminal Pulmonary Angioplasty | PAH Targeted MedicationChina
-
University Hospital Inselspital, BerneUniversity of BernWithdrawn
-
Abbott Medical DevicesWithdrawnPeripheral Vascular Disease