Feasibility Clinical Trial Using the SPUR System to Demonstrate Safety and Efficacy.

NCT03669458 | Completed FDA Device

• 1 other identifier: CP-001
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the safety and effectiveness of the Spur System in a patient population with infrapopliteal artery disease (tibioperoneal, anterior/posterior tibial and peritoneal arteries) when used in conjunction with substance/drug coated balloons.

Conditions

Critical Limb Ischemia

Outcome Measures

Primary Outcomes (1)

• Demonstrate binary arterial flow at 6 months

  The primary effectiveness endpoint assess arterial flow using duplex ultrasound at 6 months post procedure.

  6 months

Secondary Outcomes (2)

• MALE

  30 days

• All cause perioperative death (30 days)

  30 days

Other Outcomes (3)

• Device and procedure related death through 30 days post procedure.

  30 days

• Clinically driven target lesion revascularization through 12 months post procedure.

  12 months

• Freedom from major target amputation through 30 days from the device or procedure

  30 days

Study Arms (3)

Arm 1: BTK intervention with SPUR/DCB

EXPERIMENTAL

Below the knee peripheral intervention using SPUR/DCB.

Device: Below the Knee peripheral intervention

Arm 2: BTK intervention using SPUR Only

EXPERIMENTAL

Below the knee peripheral intervention using SPUR only.

Device: Below the Knee peripheral intervention

ARM 3: BTK intervention using DCB Only

EXPERIMENTAL

Below the knee peripheral intervention using DCB only.

Device: Below the Knee peripheral intervention

Interventions

Below the Knee peripheral intervention DEVICE

Treatment of infrapopliteal disease using SPUR/DCB, SPUR only and DCB alone

Also known as: DCB Treatment, SPUR with DCB treatment

ARM 3: BTK intervention using DCB Only; Arm 1: BTK intervention with SPUR/DCB; Arm 2: BTK intervention using SPUR Only

Eligibility Criteria

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

You may qualify if:

• Patient is willing and able to provide informed consent and able to comply with the study protocol.
• Peripheral arterial disease that can be treated using PTA.
• Life expectancy \>1 year in the investigator's opinion
• Male or non-pregnant female \> 18 years of age
• Patent inflow artery
• Target vessel(s) reconstitutes(s) at or above the ankle, excluding the dorsalis pedis and the calcaneal branch of the posterior tibial artery
• Target lesion starts at or below 3 cm below the tibial plateau as measured by angiography
• Target vessel for Spur device is ≥ 3.5 mm (4mm); ≥ 2.5 mm (3mm) in diameter by visual estimate.
• Lesion(s) must be able to be treated with a minimum of one Spur or PTA or DCB product.
• Infrapopliteal lesion(s) that are located in either the left or right leg Infrapopliteal artery(s) may be treated with only one modality per artery: DCB, Spur or Spur/DCB.
• Arterial length/diameter and quantity must be able to be treated with DCB or Spur or Spur/DCB
• The treated segment is defined as the total length of artery treated with PTA.
• The cumulative treated segment of infrapopliteal artery(s) must be ≤34.0 cm.
• Lesions in the treated segment may be continuous or may have gaps present between stenosis or occlusions
• Patient has Rutherford Classification of 3-5.

You may not qualify if:

• Subject unwilling or unlikely to comply with the appropriate follow up time for the duration of the study
• Prior stent(s) or bypass surgery within the target vessel(s)
• Target lesion is located within an aneurysm or associated with an aneurysm in the vessel segment either proximal or distal to the target lesion.
• Previous treatment failure of inflow arteries (Iliac, SFA and popliteal) which required a surgical procedure.
• Previous PTA of the target vessel within 30 day prior to index procedure
• Angiographic evidence of thrombus within target limb.
• Subject has an active infection of the foot, including pus or wet gangrene that is not controlled at the time of the procedure.
• Planned major (above the ankle) amputation of the target limb
• Recent MI or stroke \< 30 days prior to the index procedure.
• Heart failure with Ejection Fraction \< 30%
• Impaired renal function (GFR \<30 mL/min) and patients on dialysis
• Subject with vasculitis, systemic Lupus Erythematosus or Polymyalgia Rheumatica.
• Patient receiving systemic corticosteroid therapy.
• Inability to tolerate concomitant antiplatelet and oral anticoagulation therapy.
• Known allergies or sensitivities to heparin, aspirin (ASA), 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.

Sponsors & Collaborators

• ReFlow Medical, Inc.: lead
• Syntropic Corelab: collaborator
• Massachusetts General Hospital: collaborator

Study Sites (1)

Instituto Nacional de la Diabetes (INDEN)

Santo Domingo, Dominican Republic

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Jihad Mustapha, MD

  Advanced Cardiac & Vascular Centers

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A minimum of 10 patients will be enrolled for treatment of BTK disease

Study Record Dates

• First Submitted: August 29, 2018
• First Posted: September 13, 2018
• Study Start: October 6, 2017
• Primary Completion: June 4, 2019
• Study Completion: June 4, 2019
• Last Updated: August 20, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

DO (1)