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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2015 by Spectranetics Corporation
Sponsor:
Information provided by (Responsible Party):
Spectranetics Corporation
ClinicalTrials.gov Identifier:
NCT01912937
First received: July 10, 2013
Last updated: March 9, 2015
Last verified: March 2015

July 10, 2013
March 9, 2015
June 2013
January 2016   (final data collection date for primary outcome measure)
  • Paclitaxel Levels [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: up to 12 months ] [ Designated as safety issue: Yes ]
    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.
Same as current
Complete list of historical versions of study NCT01912937 on ClinicalTrials.gov Archive Site
Measurements of Pharmacokinetics variables: Cmax, Tmax, AUC [ Time Frame: (0-t) and half-life ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Study of Drug-coated Angioplasty Balloons in the Superficial Femoral or Popliteal Arteries:
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

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).

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).

Interventional
Phase 2
Phase 3
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Peripheral Artery Disease
Device: 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)
Experimental: DCB Arm
Angioplasty treatment with the CVI Paclitaxel-Coated, Percutaneous Transluminal Angioplasty (PTA) Balloon Catheter (CVI Paclitaxel-coated PTA Catheter)
Intervention: Device: Angioplasty treatment with the CVI Drug-coated Balloon (DCB)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
25
January 2017
January 2016   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact: Colleen Holthe 763-591-3313
Contact: Jill Farenbaugh 763-591-3436
New Zealand
 
NCT01912937
TP-1363
Yes
Spectranetics Corporation
Spectranetics Corporation
Not Provided
Principal Investigator: Andrew Holden, MD Auckland City Hospital
Spectranetics Corporation
March 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP