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

NCT03807531 | Active Not Recruiting DMC

• 1 other identifier: CP-002
• Study Type: interventional
• Target: 100
• Locations: 3 countries
• Sites: 6

Brief 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.

Conditions

Peripheral Arterial Disease

Outcome Measures

Primary Outcomes (2)

• Primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization)

  The primary performance endpoint will be primary patency of treated lesion sites by duplex ultrasound in subjects who are free from clinically driven TLR (target lesion revascularization).

  6 months

• Freedom from device and procedure-related death through 30 days post-procedure

  The primary safety endpoint is freedom from device and procedure-related death through 30 days post-procedure

  30 days

Secondary Outcomes (3)

• Freedom from clinically driven target lesion revascularization through 6 months post procedure.

  6 months

• Decrease in Rutherford class score at 3, 6 and 12 months.

  3, 6, and 12 months

• Wound healing for subjects with Rutherford class 5 at 6 and 12 months, as assessed by the investigator using WIfI score and descriptive characteristics, including change in wound size measured by any decrease in wound surface area.

  6 and 12 months

Study Arms (1)

Treatment with TSS

OTHER

This is a single-arm study. Participating subjects will be treated with the Temporary Spur Stent System (TSS)

Device: Temporary Spur Stent System

Interventions

Temporary Spur Stent System DEVICE

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

Also known as: G2-SPUR04X60, G2-SPUR03X60, G2-SPUR02x60

Treatment with TSS

Eligibility Criteria

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

You may qualify if:

• Subject is willing and able to provide informed consent and able to comply with the study protocol.
• Life expectancy \>1 year in the investigator's opinion
• Subject is \> 18 years of age.
• Subject is Rutherford class 3-5.
• Stenotic, restenotic, or occlusive lesions located in the infrapopliteal vessels, with target lesion that can be successfully crossed with a guidewire.
• Target lesion must meet lesion-specific criteria in pre-screening by angiography (pre-screening with CTA, MRA or selective angiography may be performed prior to the index procedure)
• Target vessel(s) reconstitutes(s) at or above the medial malleolus, with the target treated segment extending no more than 10 mm beyond the medial malleolus.
• Note: If the anterior tibial or posterior tibial arteries are treated, there must be inline flow to the foot.
• If the peroneal artery is treated, there must be at least one collateral supplying the foot.
• Target lesion must begin no higher than the tibioperoneal trifurcation (popliteal arteries excluded).
• Target vessel reference diameter is measured to be between 2.0 mm to 4.5 mm in diameter, assessed by one of the following methods after successful completion of guidewire crossing of the lesion site:
• Intravascular Ultrasound (IVUS)
• Optical Coherence Tomography (OCT)
• Quantitative Vascular Angiography (QVA).
• Lesion length must be \> 30 mm and \< 150 mm.

You may not qualify if:

• Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study in the opinion of the investigator.
• Subject is pregnant or planning to become pregnant during the course of the trial.
• Subject has an active infection that is not controlled at the time of the procedure, including septicemia or bacteremia.
• Subject has osteomyelitis or a heel wound.
• Planned major (above the ankle) amputation of the target limb. A planned or previous minor (transmetatarsal or digit amputation) is permitted
• Recent myocardial infarction or stroke \< 90 days prior to the index procedure.
• Heart failure with Ejection Fraction \< 35%
• Impaired renal function (eGFR \<25 mL/min) within 30 days of procedure and subjects on dialysis
• Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
• Subject receiving chronic or intravenous corticosteroid therapy.
• Inability to tolerate dual antiplatelet and oral anticoagulation therapy.
• Known allergies or sensitivities to heparin, antiplatelet, or other anticoagulant therapies which could not be substituted, and/or paclitaxel or an allergy to contrast media that cannot be adequately pre-treated prior to the index procedure.
• The subject is currently enrolled in another investigational device or drug trial that may interfere with the endpoints of this study.
• Known allergy to nitinol or nickel.
• Prior stent(s) within the target vessel, or bypass surgery of or within the target vessel(s)

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead
• ClinLogix. LLC: collaborator

Study Sites (6)

Klinikum Hochsauerland Klinik für Angiologie

Arnsberg, Germany

Location

Universitats Herzzentrum Bad Krozingen

Bad Krozingen, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Germany

Location

RoMed Klinikum Rosenheim

Rosenheim, Germany

Location

Auckland City Hospital

Auckland, 1023, New Zealand

Location

Ospedale di Lugano Civico

Lugano, Switzerland

Location

Related Publications (1)

• Mills JL Sr, Conte MS, Armstrong DG, Pomposelli FB, Schanzer A, Sidawy AN, Andros G; Society for Vascular Surgery Lower Extremity Guidelines Committee. The Society for Vascular Surgery Lower Extremity Threatened Limb Classification System: risk stratification based on wound, ischemia, and foot infection (WIfI). J Vasc Surg. 2014 Jan;59(1):220-34.e1-2. doi: 10.1016/j.jvs.2013.08.003. Epub 2013 Oct 12.

  PMID: 24126108 BACKGROUND

MeSH Terms

Conditions

Peripheral Arterial Disease

Condition Hierarchy (Ancestors)

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

Study Officials

• Andrew Holden, MBChB

  Auckland Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter, non-randomized, single-arm study

Study Record Dates

• First Submitted: January 11, 2019
• First Posted: January 17, 2019
• Study Start: July 11, 2019
• Primary Completion: April 30, 2023
• Study Completion (Estimated): June 1, 2028
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1); NZ (1); DE (4)