Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:

Phase 2

Completed

• Conditions: Peripheral Artery Disease
• Interventions: Device: Angioplasty treatment with the CVI Drug-coated Balloon (DCB)

• Registration Number: NCT01912937
• Lead Sponsor: Spectranetics Corporation

Brief Summary

To describe the pharmacokinetics of paclitaxel in the blood delivered from a paclitaxel coated percutaneous angioplasty balloon catheter as a result of treatment of de novo or restenotic lesion(s), occluded/stenotic or re-occluded/restenotic lesion(s).

Detailed Description

This study investigates the inhibition of restenosis using the CVI Paclitaxel-coated PTA Catheter in the treatment of de-novo occluded/stenotic or re-occluded/ restenotic superficial femoral or popliteal arteries. The proposed clinical study will be a prospective, non-randomized, single arm, multi-center, pharmacokinetic study. The objective of the study is to describe the pharmacokinetics of paclitaxel in the blood delivered from the CVI Paclitaxel-coated PTA Catheter as a result of de novo occluded/restenotic or re-occluded/restenotic lesion(s).

Study Timeline

• Study Start: 2013-06
• Study First Submitted: 2013-07-10
• Study First Submitted QC: 2013-07-29
• Study First Posted: 2013-07-31
• Primary Completion: 2016-06
• Study Completion: 2017-07
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-16
• Last Update Posted: 2017-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

Inclusion Criteria

• Male or non-pregnant female greater than or equal to 18 years of age.
• Subjects with symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery.

Exclusion Criteria

• Pregnant or lactating females.
• Known intolerance to study medications, paclitaxel or contrast agents that in the opinion of the investigator cannot be adequately pre-treated.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DCB Arm	Angioplasty treatment with the CVI Drug-coated Balloon (DCB)	Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)

Primary Outcome Measures

Name	Time	Method
Paclitaxel Levels	up to 6 months	Measurement of paclitaxel concentration in the circulating blood immediately after last balloon deployment, 1, 4, 24 hours, 7, 14, 30, 60 days and 6 months (if applicable) post-procedure.
Freedom from Events as a Safety Measure (Composite)	up to 12 months	Freedom from device and procedure-related death through 30 days post-procedure; and freedom from target limb major amputation and clinically-driven target lesion revascularization through 12 months post-procedure.

Secondary Outcome Measures

Name	Time	Method
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC	(0-t) and half-life

Trial Locations

Locations (2)

Clinical Trials New Zealand; 🇳🇿 Hamilton, New Zealand

Auckland City Hospital; 🇳🇿 Auckland, New Zealand