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
1 other identifier
interventional
80
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
December 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 4, 2014
CompletedFirst Posted
Study publicly available on registry
April 10, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 26, 2015
February 1, 2015
9 months
April 4, 2014
February 25, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Primary endpoint: Angiographic late lumen loss
difference between minimum lumen diameter after intervention and follow up.
6Month
Secondary Outcomes (1)
Secondary safety endpoint: Major Adverse Event (MAE) rate
6Months
Study Arms (1)
CVI Drug Coated Balloon
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jewish Hospital Berlin
Berlin, 13347, Germany
Related Publications (1)
Gray WA, Jaff MR, Parikh SA, Ansel GM, Brodmann M, Krishnan P, Razavi MK, Vermassen F, Zeller T, White R, Ouriel K, Adelman MA, Lyden SP. Mortality Assessment of Paclitaxel-Coated Balloons: Patient-Level Meta-Analysis of the ILLUMENATE Clinical Program at 3 Years. Circulation. 2019 Oct;140(14):1145-1155. doi: 10.1161/CIRCULATIONAHA.119.040518. Epub 2019 Sep 30.
PMID: 31567024DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Henrik Schröder, MD
Jewish Hospital Berlin
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2014
First Posted
April 10, 2014
Study Start
December 1, 2011
Primary Completion
September 1, 2012
Study Completion
December 1, 2014
Last Updated
February 26, 2015
Record last verified: 2015-02