Peripheral Arterial Disease
Conditions
Brief summary
To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD).
Detailed description
Purpose: To evaluate vessel lumen quality (gain) and patient outcomes based on treatment with a predetermined laser treatment protocol in patients presenting with varying lesion types or morphologies: homogenous (plaques with a uniform texture-smooth and regular), heterogeneous (plaques with non-uniform texture-smooth and irregular surface), calcific (consisting of calcium) and restenotic (reoccurring narrowing of the vessel following prior treatment) associated with peripheral arterial disease (PAD). Participants: 60 patients with PAD undergoing a revascularization procedure (treatment of a narrowed blood vessel) involving above the knee (ATK) lesion(s) eligible for treatment with laser atherectomy (a option for treatment of blocked blood vessels.) Procedures (methods): Patients' qualifying lesions will be assessed with angiography (a test that uses a special dye and camera to take pictures of the blood flow in an artery) and intravascular ultrasound (IVUS) and categorized (homogenous, heterogeneous, calcific or restenotic) and determined to be treatable with laser atherectomy per standard of care. Qualified patients will undergo standard of care treatment with the Spectranetics Turbo-Power laser catheter for three passes with increasing settings 'low' (40/60), 'medium' (50/40) and 'high'(60/60), respectively. After each pass, assessments of lumen quality and residual stenosis (narrowing still present after treatment) will be determined by angiogram and IVUS. The operator may finish the procedure per standard of care/investigator discretion after the protocol defined laser passes are completed.
Interventions
DEVICELaser Atherectomy
The Turbo-Power is laser atherectomy catheter designed for treatment of de novo or restenotic lesions in native infrainguinal arteries and for the treatment of femoropopliteal artery in-stent restenosis (ISR) in bare nitinol stents with adjunctive percutaneous transluminal angioplasty (PTA).
Sponsors
Spectranetics Corporation
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Patient age at least 18 years. 2. Patient has been informed of the nature of the study, agrees to participate and has signed an approved consent form. 3. Rutherford category 1, 2, 3, or 4 4. Subject Patient presents with clinical evidence of PAD requiring endovascular intervention. 5. Target lesion access must use the femoral approach that will accommodate at least a 7Fr sheath. 6. Angiographic evidence of significant restenosis (≥ 50% by visual estimate).
Exclusion criteria
1. Inability to obtain informed consent. 2. Life expectancy \< 12 months. 3. Pregnancy, suspected pregnancy, or breastfeeding during study period. (Patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment. 4. Any evidence of hemodynamic instability prior to procedure/randomization 5. Coagulopathy or clotting disorders. 6. Present or suspected systemic infection or osteomyelitis affecting target limb. 7. Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytic, etc).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of stenosis | immediately post-procedure | 1\. Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS). |
Countries
United States
Outcome results
None listed