Drug-coated angioplasty balloons for subjects with constriction or blockage in the leg arteries, specifically the Superficial Femoral or Popliteal Arteries: A pharmacokinetic study.

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12613000336785

Acronym

Spectranetics ILLUMENATE PK

Enrollment

Registered

2013-03-27

Start date

2013-06-26

Completion date

2015-06-03

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

The study was designed 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).

Interventions

Single use of a Paclitaxel-coated Percutaneous Transluminal Angioplasty Balloon Catheter with a dose density of 2.0 micrograms/mm^2 used in the Superficial Femoral or Popliteal Arteries. A needle will be used to gain access to the blood vessel, then a narrow tube with the balloon inside of it will be moved to the area in the artery where the doctor needs the balloon to be positioned. The doctor will then inflate the balloon and deflate the balloon as necessary. The balloon will then be remov

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Subjects can be enrolled if they have symptomatic leg ischemia, requiring treatment of the Superficial Femoral Artery (SFA) or popliteal artery; Rutherford classification of 2, 3 or 4; de novo or restenotic lesion(s) >70% within the SFA and/or popliteal artery that are greater than or equal to 3 cm and less than or equal to 20 cm in cumulative total length with a reference vessel diameter of greater than or equal to 4 mm and less than or equal to 6 mm and with at least one patent outflow vessel.

Exclusion criteria

Patients will be excluded if they have a known intolerance to study medications, paclitaxel or contrast agents, a drug coated or drug eluting stent or balloon implanted/used within 12 months of the interventional procedure, require the use of adjunctive therapies or have prohibitive calcification that precludes adequate treatment.

Outcome results