A clinical study to evaluate the Senza™ spinal cord stimulation system in patients with pain from vascular disease

Completed

• Conditions: Chronic intractable pain from vascular disease; Signs and Symptoms

• Registration Number: ISRCTN27921933
• Lead Sponsor: evro Corp

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-14
• Last Update Posted: 8 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1. Have been diagnosed with chronic, intractable ischemic pain secondary to vascular disease with non-reconstructable, predominantly unilateral critical limb ischemia, with possible sub-diagnoses including (but not limited to) peripheral arterial disease, peripheral vascular disease, and diabetic peripheral neuropathy
2. Considering daily activity and rest, have average lower limb pain intensity of = 5 out of 10 on the Numerical Rating Scale (NRS) at enrollment
3. Have limb ischemia condition rated with Fontaine class IIb or III
4. Have no ulcers
5. Have TcPO2 > 10 mm of Hg in the affected limb
6. Be on stable pain medications, as determined by the Investigator, for at least 28 days prior to enrolling in this study and be willing to stay on those medications
7. Be 18 years of age or older at the time of consent
8. Be willing and able to comply with study-related requirements, procedures, and visits
9. Be capable of subjective evaluation, able to read and understand written questionnaires, and are able to read, understand and sign the written informed consent
10. Have adequate ability to use a patient programmer and recharger as determined by the Investigator

Exclusion Criteria

1. Have undergone destructive sympathectomy as treatment for pain due to chronic critical limb ischemia
2. Have a medical condition or pain in other area(s), not intended to be treated with SCS, that could interfere with study procedures, accurate pain reporting, and/or confound evaluation of study endpoints, as determined by the Investigator (such as primary headache diagnosis and fibromyalgia)
3. Have evidence of an active disruptive psychological or psychiatric disorder or other known condition significant enough to impact perception of pain, compliance of intervention and/or ability to evaluate treatment outcome
4. Have a current diagnosis of a progressive neurological disease such as multiple sclerosis, chronic inflammatory demyelinating polyneuropathy, rapidly progressive arachnoiditis, brain or spinal cord tumor, and/or central deafferentation syndrome
5. In the target lower limb, have previous major amputation, lesions with wet gangrene, or deep infections.
6. Have a current diagnosis of a coagulation disorder, such as bleeding diathesis that would put patient at any increased risk of excessive bleeding during SCS procedure, as determined by the investigator(s)
7. Be currently treated with anticoagulation therapy which cannot be safely managed temporarily for the duration of the SCS trial and implant procedures, as determined by the investigator(s)
8. Any previous history of back surgery that would inhibit access to epidural space for lead placement targets
9. Be benefitting from an interventional procedure and/or surgery to treat chronic, intractable unilateral lower limb pain from vascular disease (Subjects should be enrolled at least 30 days from last benefit)
10. Have an existing drug pump and/or another active implantable device (switched On or Off) such as a pacemaker or other SCS devices. Additionally, have previously trialed and/or been implanted with an SCS device.
11. Have a condition currently requiring or likely to require the use of MRI of the trunk or therapeutic diathermy
12. Have metastatic malignant disease or active local malignant disease
13. Is believed to or has prognosis of a life expectancy less than 1 year
14. Have an active systemic or local infection
15. Be pregnant (if female and sexually active, subject must be using a reliable form of birth control, be surgically sterile or be at least 2 years post-menopausal)
16. Have within 6 months of enrollment a significant untreated addiction to dependency producing medications or have been a substance abuser (including alcohol and illicit drugs)
17. Be concomitantly participating or planned to be participating in another clinical study
18. Be involved in an injury claim under current litigation

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of subjects who achieve 30% or greater pain reduction based on NRS pain scores from baseline during the Later Evaluation Period at 3 months for any lead placements

Secondary Outcome Measures

Name	Time	Method
1. Responder rate as measured by NRS at 3, 6 and 12 months<br>2. Proportion of subjects who prefer a specific stimulation setting at 3 months<br>3. Change in pain (NRS) as measured by NRS from baseline at 3, 6 and 12 months<br>4. Change in claudication distance as measured by distance walked from baseline at 3, 6 and 12 months<br>5. Change in PPG Toe pressure as measured by systolic pressures at the toe from baseline at 3, 6 and 12 months<br>6. Change in TcPO2 measurements as measured by transcutaneous oxygen pressure from baseline at 3, 6 and 12 months<br>7. Impressions of change, as measured by CGIC and PGIC questionnaire at 3, 6 and 12 months