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

Primary Purpose

Peripheral Artery Disease

Status
Completed
Phase
Phase 2
Locations
New Zealand
Study Type
Interventional
Intervention
Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
Sponsored by
Spectranetics Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Paclitaxel, Percutaneous Transluminal Angioplasty, Balloon Catheter, Pharmacokinetic, Peripheral Artery Disease, PAD

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Auckland City Hospital
  • Clinical Trials New Zealand

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

DCB Arm

Arm Description

Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)

Outcomes

Primary Outcome Measures

Paclitaxel Levels
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)
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

Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC

Full Information

First Posted
July 10, 2013
Last Updated
October 16, 2017
Sponsor
Spectranetics Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT01912937
Brief Title
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
Acronym
PK
Official Title
ProspectIve, SingLe-Arm, MuLti-Center, Pharmacokinetic Study to EvalUate TreatMent of Obstructive SupErficial Femoral Artery or Popliteal LesioNs With A Novel PacliTaxel-CoatEd Percutaneous Angioplasty Balloon
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
June 2013 (Actual)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
July 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Spectranetics Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Artery Disease
Keywords
Paclitaxel, Percutaneous Transluminal Angioplasty, Balloon Catheter, Pharmacokinetic, Peripheral Artery Disease, PAD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DCB Arm
Arm Type
Experimental
Arm Description
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Intervention Type
Device
Intervention Name(s)
Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
Intervention Description
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Primary Outcome Measure Information:
Title
Paclitaxel Levels
Description
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.
Time Frame
up to 6 months
Title
Freedom from Events as a Safety Measure (Composite)
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC
Time Frame
(0-t) and half-life

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Holden, MD
Organizational Affiliation
Auckland City Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Auckland City Hospital
City
Auckland
Country
New Zealand
Facility Name
Clinical Trials New Zealand
City
Hamilton
Country
New Zealand

12. IPD Sharing Statement

Citations:
PubMed Identifier
31567024
Citation
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.
Results Reference
derived
PubMed Identifier
28729250
Citation
Krishnan P, Faries P, Niazi K, Jain A, Sachar R, Bachinsky WB, Cardenas J, Werner M, Brodmann M, Mustapha JA, Mena-Hurtado C, Jaff MR, Holden AH, Lyden SP. Stellarex Drug-Coated Balloon for Treatment of Femoropopliteal Disease: Twelve-Month Outcomes From the Randomized ILLUMENATE Pivotal and Pharmacokinetic Studies. Circulation. 2017 Sep 19;136(12):1102-1113. doi: 10.1161/CIRCULATIONAHA.117.028893. Epub 2017 Jul 20.
Results Reference
derived

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

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