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OpenTrials
Completed

NCT Number: NCT02110524

CVI Drug Coated Balloon First In Human Trial

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.

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Key information

Conditions

Peripheral Arterial Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Peripheral Vascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jewish Hospital Berlin

Berlin, 13347, Germany

About this study

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

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Percutaneous Transluminal Angioplasty

Device

Other names: CVI Paclitaxel-coated, Percutaneous Transluminal Angioplasty (PTA) Balloon, Catheter

Primary outcomes

  1. Primary endpoint: Angiographic late lumen loss

    Time frame: 6Month

    difference between minimum lumen diameter after intervention and follow up.

Secondary outcomes

  1. 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).

Sponsors and collaborators

Lead sponsor

Spectranetics Corporation

Industry

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2012
Study completion
2014
First posted
Apr 10, 2014
Registry last updated
Feb 26, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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