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

NCT03669458 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2020-08-20

No results posted yet for this study

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

Interventions

DEVICE

Below the Knee peripheral intervention

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

Sponsors & Collaborators

  • Syntropic Corelab

    collaborator UNKNOWN

  • Massachusetts General Hospital

    collaborator OTHER

  • ReFlow Medical, Inc.

    lead INDUSTRY

Principal Investigators

  • Jihad Mustapha, MD · Advanced Cardiac & Vascular Centers

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-10-06
Primary Completion
2019-06-04
Completion
2019-06-04
FDA Device
Yes

Countries

  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03669458 on ClinicalTrials.gov