NCT03807531

A Study of the Temporary Spur Stent for the Treatment of Narrowing and Blockages in the Arteries Below the Knee

A Non-randomized Trial of the Temporary Spur Stent System for the Treatment of Lesions Located in the Infrapopliteal Arteries Outside of the United States

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: ReFlow Medical, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS). The TSS is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions. This study is a prospective, non-randomized, multicenter, single arm trial, with sites in New Zealand, Germany, and Switzerland. At least two and no more than 10 sites are expected to participate, with 100 subjects enrolled (no more than 40 at a single site). The study follow up will take place over a period of 365 days. A vessel recoil substudy will be included for a select group of subjects.

Detailed description

The purpose of this clinical study is to evaluate the performance and safety of the Temporary Spur Stent System (TSS) for subjects with infrapopliteal arterial disease. The Temporary Spur Stent System is intended for use in conjunction with a commercially available drug coated balloon in the infrapopliteal arteries for the treatment of de novo or restenotic lesions. The TSS has been developed to provide another treatment option for patients with Peripheral Arterial Disease (PAD), and Critical Limb Ischemia (CLI). Up to 100 subjects will be treated with the Temporary Spur Stent System in conjunction with an approved Drug Coated Balloon (DCB). No less than 1 subject and no more than 40 subjects will be enrolled at a single site. A vessel recoil substudy is included in the trial. The purpose of this study is to evaluate vessel recoil in a select group of subjects (no more than 10 per site, up to 35 subjects in total). This will be conducted by obtaining measurements using Optical Coherence Tomography (OCT), Intravascular Ultrasound (IVUS), or Quantitative Vascular Analysis (QVA) of the target vessel during the index procedure. The statistical analysis for this trial will use as a comparator a performance goal derived from a meta-analysis of infrapopliteal balloon angioplasty. Descriptive statistics may be used to describe other data points. Subjects will be asked to participate in a baseline evaluation visit, the index procedure, a 30 day follow up visit, a 90 day follow up visit, a 180 day follow up visit, and a 365 day follow up visit. The baseline evaluation and index procedure visits may be combined. At each follow up visit, the subject will undergo a physical exam with wound evaluation (if applicable) including pictures, a medication history and compliance review, Ankle Brachial and Toe Brachial Indices (ABI and TBI), a duplex ultrasound of the treated limb, review of symptoms, and Adverse Events (AE) assessment. Subjects may choose to withdraw from the study at any time, for any reason. If subjects choose to withdraw, they will be asked to undergo an unscheduled study visit consisting of the aforementioned procedures.

Conditions

• Peripheral Arterial Disease

Interventions

Type	Name	Description
DEVICE	Temporary Spur Stent System	Participating subjects that meet inclusion and exclusion criteria will undergo treatment of infrapopliteal occlusions and stenoses with the Temporary Spur Stent System according to protocol guidelines

Timeline

• Start date: 2019-07-11
• Primary completion: 2023-04-30
• Completion: 2028-06-01
• First posted: 2019-01-17
• Last updated: 2023-11-18

Locations

6 sites across 3 countries: Germany, New Zealand, Switzerland