An Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies

Peripheral Arterial Disease Clinical Trial

— REX  

Official title:

REX - A Pilot Evaluation of a Clinical Algorithm With Turbo-Power Following Treatment of Specific Morphologies

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02921542
• Other study ID #: 16-0393
• Status: Completed
• Start date: August 15, 2016
• Est. completion date: May 1, 2019

Study information

• Verified date: July 2019
• Source: Spectranetics Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 57
• Est. completion date: May 1, 2019
• Est. primary completion date: May 15, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Peripheral Arterial Disease
• Peripheral Vascular Diseases

Intervention

Device:
• Laser 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).

Locations

Country	Name	City	State
United States	Rex Hospital	Raleigh	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reduction of stenosis	1. Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS).	immediately post-procedure