Study of SilverHawk®/TurboHawk® in Lower Extremity Vessels (DEFINITIVE™ LE)

Browse trials for

• Peripheral Arterial Disease 1,543
• Peripheral Vascular Diseases 1,020
• Chronic Limb-Threatening Ischemia 343

Keywords

• PAD

Peripheral Arterial Disease

1,543 studies on the registry are indexed under Peripheral Arterial Disease; 282 are open to participants now.

This study's enrollment of 800 is above the median of 73 across 1,067 interventional studies indexed under Peripheral Arterial Disease.

Lead sponsor

Medtronic Endovascular is the lead sponsor of 50 studies on the registry; 3 are open to participants now.

Of its 5 completed or terminated interventional studies of FDA-regulated products, 4 (80%) have results posted.

Study arms

• Other
  Atherectomy

  All patients enrolled in this single-arm study were treated with directional atherectomy.

  Device: SilverHawk & TurboHawk Peripheral Plaque Excision System

Interventions

• DeviceSilverHawk & TurboHawk Peripheral Plaque Excision System

  Removal of atherosclerotic plaque from artery walls.

  Also known as: SilverHawk (Atherectomy), TurboHawk (Atherectomy)

Primary outcomes

1. Primary Patency Rate (in Patients Treated for Claudication RCC 1-3)

   The primary endpoint analysis for claudication subjects was primary patency rate at one year, defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who had claudication (RCC of 1 - 3) at time of enrollment.

   Time frame: One year

2. Amputation-Free Survival at 1 Year (in Patients Treated for Critical Limb Ischemia RCC 4-6)

   The primary endpoint for CLI was amputation-free survival at one year, defined as freedom from a major, unplanned amputation of the target limb through the 1-year visit in subjects who have CLI (RCC 4 - 6) at time of enrollment.

   Time frame: One Year

Secondary outcomes

1. Device Success (in All Patients Enrolled)

   Device success was defined as ≤ 30% residual stenosis following use of the SilverHawk device, as measured by angiography, without adjunctive endovascular interventions or periprocedural complications.

   Time frame: Immediately following use of the SilverHawk device

2. Procedural Success (in All Patients Enrolled)

   Procedure success was defined as ≤ 30% residual stenosis following use of SilverHawk device and adjunctive endovascular interventions (if required) as measured by angiography without periprocedural complications.

   Time frame: Immediately following use of the SilverHawk and adjunctive devices

3. Major Adverse Event Rate (in All Patients Enrolled)

   Major Adverse Event Rate (MAE) at 30 Days was defined as clinically-driven target vessel revascularization (TVR), major unplanned amputation of treated limb, or all-cause mortality within 30 days post procedure, as classified by the Clinical Events Committee (CEC).

   Time frame: 30 Days

4. Major Adverse Event Rate (in All Patients Enrolled)

   Major Adverse Event Rate at One Year was defined as clinically-driven target vessel revascularization, major unplanned amputation of the treated limb, or all-cause mortality within one year, as classified by the Clinical Events Committee (CEC).

   Time frame: One Year

5. Improvement in Walking Impairment Questionnaire Score (in Patients Treated for Claudication RCC 1-3)

   WIQ includes a measurement for walking distance, walking speed, and climbing stairs collected at baseline and one year, presented for subjects who have claudication. The Walking Improvement Questionnaire (WIQ) is a validated method to assess objective improvement in functional walking ability of subjects with intermittent claudication. Difficulty walking a distance was self-assessed at baseline by the patient (prior to treatment) and at the one year follow up visit. Speed and stair climbing ability were assessed by the treating physician. Scale ranges from 0 (minimum) to 100 (maximum), with larger numbers representing better outcomes. An increase in WIQ scores at 1 year represents an improvement over baseline.

   Time frame: Baseline and 1 Year

6. Improvement in Rutherford Clinical Category (in All Patients Enrolled)

   Change in RCC at One Year was assessed and percentage of subjects with an improvement in clinical status indicated by a decrease of one or more in RCC at one year compared to baseline, that is attributable to the treated limb (in cases of bilateral disease), was calculated.

   Time frame: 1 Year

7. Ankle-Brachial Index (in All Patients Enrolled)

   Change in Ankle-Brachial Index at One Year was calculated and percentage of subjects with an increase (improvement) in the ankle-brachial index (ABI) at one year compared to baseline in subjects with compressible arteries and baseline ABI \< 0.9 was calculated.

   Time frame: 1 Year

8. Secondary Patency (in Patients Treated for Claudication RCC 1-3)

   Secondary patency was defined as measured by duplex ultrasound peak systolic velocity ratio ≤ 3.5 maintained by repeat percutaneous intervention in subjects who have claudication; estimated as freedom from loss of patency by the Kaplan-Meier method at one year.

   Time frame: One Year

9. Primary Patency (in Patients Treated for Critical Limb Ischemia RCC 4-6)

   The primary patency for CLI was defined by duplex ultrasound measurement of peak systolic velocity ratio ≤ 3.5 at the target lesion(s) with no clinically-driven reintervention within the treated segment in subjects who have CLI at time of enrollment

   Time frame: One Year

10. Amputation-Free Survival (in Patients Treated for Claudication RCC 1-3)

    Amputation-Free Survival in Claudicants at One Year was defined as freedom from a major, unplanned amputation of the target limb through the one year visit in subjects who have claudication at time of enrollment.

    Time frame: One Year

11. Improvement in Wound Healing (in Patients Treated for Critical Limb Ischemia and With Wounds RCC 5-6)

    Wound healing at three months was defined as a decrease of at least one Wagner Classification grade of the wound at three months compared to baseline in subjects who have Rutherford Clinical Category score of 5 or 6 at the time of enrollment.

    Time frame: 3 months

12. Alternative Patency Rate (Peak Systolic Velocity ≤ 2.4) at 1 Year (in Patients Treated for Claudication RCC 1-3)

    Defined by the duplex ultrasound measurement of peak systolic velocity ration ≤ 2.4 at the target lesion (s) with no clinically-driven re- intervention with the treated segment in subjects who have claudication at time of enrollment.

    Time frame: 1 year

Baseline characteristics

Publications

• McKinsey JF, Zeller T, Rocha-Singh KJ, Jaff MR, Garcia LA; DEFINITIVE LE Investigators. Lower extremity revascularization using directional atherectomy: 12-month prospective results of the DEFINITIVE LE study. JACC Cardiovasc Interv. 2014 Aug;7(8):923-33. doi: 10.1016/j.jcin.2014.05.006. PubMed 25147039 ↗