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

NCT02921542 | Completed

• 1 other identifier: 16-0393
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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).

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (1)

• Reduction of stenosis

  1\. Final reduction of stenosis post procedure, determined by angiogram and intravascular ultrasound (IVUS).

  immediately post-procedure

Study Arms (4)

Homogenous Lesions

Device: Laser Atherectomy

Heterogenous Lesions

Device: Laser Atherectomy

Calcific Lesions

Device: Laser Atherectomy

Restenotic Lesions

Device: Laser Atherectomy

Interventions

Laser Atherectomy DEVICE

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).

Calcific Lesions; Heterogenous Lesions; Homogenous Lesions; Restenotic Lesions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Consecutive patients with homogenous, heterogeneous, calcific, or restenotic with above the knee lesions eligible for treatment with laser atherectomy with Turbo-Power (target will be 15 patients enrolled in each category by lesions morphology).

You may qualify if:

• Patient age at least 18 years.
• Patient has been informed of the nature of the study, agrees to participate and has signed an approved consent form.
• Rutherford category 1, 2, 3, or 4
• Subject Patient presents with clinical evidence of PAD requiring endovascular intervention.
• Target lesion access must use the femoral approach that will accommodate at least a 7Fr sheath.
• Angiographic evidence of significant restenosis (≥ 50% by visual estimate).

You may not qualify if:

• Inability to obtain informed consent.
• Life expectancy \< 12 months.
• Pregnancy, suspected pregnancy, or breastfeeding during study period. (Patients of childbearing potential must have negative serum pregnancy test 7 days prior to treatment.
• Any evidence of hemodynamic instability prior to procedure/randomization
• Coagulopathy or clotting disorders.
• Present or suspected systemic infection or osteomyelitis affecting target limb.
• Contraindication to contrast media or any study-required medication (antiplatelets, anticoagulants, thrombolytic, etc).

Sponsors & Collaborators

• Spectranetics Corporation: lead

Study Sites (1)

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases

Study Officials

• George Adams, MD

  UNC Hospitals - REX

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 29, 2016
• First Posted: October 3, 2016
• Study Start: August 15, 2016
• Primary Completion: May 15, 2018
• Study Completion: May 1, 2019
• Last Updated: July 18, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)