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CompletedNCT02110524Updated Feb 26, 2015

CVI Drug Coated Balloon First In Human Trial

An interventional study of Percutaneous Transluminal Angioplasty in Peripheral Arterial Disease, sponsored by Spectranetics Corporation. Completed at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-02-26.

Sponsored by Spectranetics Corporation · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
80
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

Prospective, controlled, multi-center, open, single arm study

Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

02

Conditions studied

  • Peripheral Arterial Disease

Keywords

  • Peripheral Arterial Disease
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In context

Peripheral Arterial Disease

1,542 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 80 is close to the median of 74 across 1,066 interventional studies indexed under Peripheral Arterial Disease.

Browse Peripheral Arterial Disease studies →

Lead sponsor

Spectranetics Corporation is the lead sponsor of 19 studies on the registry; none are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
80 participants (actual)

Study arms

  • Experimental
    CVI Drug Coated Balloon

    Device: Percutaneous Transluminal Angioplasty

Interventions

  • DevicePercutaneous Transluminal Angioplasty

    Also known as: CVI Paclitaxel-coated, Percutaneous Transluminal Angioplasty (PTA) Balloon, Catheter

06

What researchers measure

Primary outcomes

  1. Primary endpoint: Angiographic late lumen loss

    difference between minimum lumen diameter after intervention and follow up.

    Time frame: 6Month

Secondary outcomes

  1. Secondary safety endpoint: Major Adverse Event (MAE) rate

    composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).

    Time frame: 6Months

07

Study locations

1 site
  • Jewish Hospital Berlin
    Berlin, 13347, Germany
08

References and documents

Publications

  • 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. PubMed 31567024 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 26, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02110524
Lead sponsor
Spectranetics Corporation
Responsible party
Sponsor
First posted
Apr 10, 2014
Start date
Dec 2011
Primary completion
Sep 2012
Completion
Dec 2014
Last update
Feb 26, 2015

Study contacts

Henrik Schröder, MD
principal investigator · Jewish Hospital Berlin

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2015. You cannot join it, but the record below documents what was studied.

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