N/A
Completed N=44
Atherectomy By Laser Ablation With Turbo-Elite
Source: ClinicalTrials.gov NCT02307370 ↗Enrolled (actual)
44
Serious AEs
32.6%
Results posted
Aug 2021
Primary outcomePrimary: Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis — 39 Participants
Summary
The primary objective for this study is to prove the safety and effectiveness of the Spectranetics Turbo-Elite catheter in atherectomy treatment for infrainguinal arteries with catheter to vessel sizing of at least 50%.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Primary Efficacy Endpoint - Mean Reduction in Percent Stenosis |
39 | — |
| PRIMARY Primary Safety Endpoint is Freedom From Major Adverse Event (MAE) |
38 | — |
| SECONDARY Final Procedure Residual Stenosis After All Therapy |
12.7 | — |
| SECONDARY Characterization of Adjunctive Therapy Use |
0; 23; 20; 14 | — |
| SECONDARY Ankle-Brachial Index (ABI) Change From Baseline to 30 Days. |
0.7; 0.9; 0.3 | — |
| SECONDARY Rutherford Class (RCC) Change |
0; 17; 0; 11; 2; 5 | — |
| SECONDARY Freedom From Target Lesion Revascularization (TLR) Through 180 Days. |
40 | — |
Eligibility Criteria
Inclusion Criteria
- PAD with Rutherford Class 1-4
- Patient is able to walk unassisted or with non-motorized assistive devices.
- Documented PAD by ABI <0.9 or previous intervention with reoccurrence of symptoms
- Documented stenosis by duplex ≥50%
Exclusion Criteria
- Patient is pregnant or breast feeding.
- Evidence of Acute Limb Ischemia within 7 days prior to procedure.
- CVA < 60 days prior to procedure.
- MI < 60 days prior to procedure.
- Known contraindication to aspirin, antiplatelet/anti-coagulant therapies required for procedure/follow up.
- Known allergy to contrast media that cannot adequately be pre-medicated prior to study procedure.
- Uncontrolled hypercoagulability or history of HIT or HITTS syndrome.
- Serum creatinine ≥ 2.5 mg/dL (unless dialysis-dependent) within one day prior to procedure.
- Patient is simultaneously participating in another investigational drug or device study that will interfere with the 30 day Safety Endpoint.
- Previously identified severe calcium in the vessel.
Data sourced from ClinicalTrials.gov (NCT02307370). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.