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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02110524

Enrollment

Registered

2014-04-10

Start date

2011-12-31

Completion date

2014-12-31

Last updated

2015-02-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Peripheral Arterial Disease

Keywords

Peripheral Arterial Disease

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.

Detailed description

Prospective, controlled, multi-center, open, single arm study Main cohort: 50; pre-specified treatment group: 30. Total patients: 80

Interventions

DEVICEPercutaneous Transluminal Angioplasty

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Primary endpoint: Angiographic late lumen loss	6Month	difference between minimum lumen diameter after intervention and follow up.

Secondary

Measure	Time frame	Description
Secondary safety endpoint: Major Adverse Event (MAE) rate	6Months	composite rate of cardiovascular death, index limb amputation and ischemia driven target lesion revascularization (TLR).

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026