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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT04025008
Other study ID # MMS-001-B
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date October 2019
Est. completion date August 2021

Study information

Verified date July 2019
Source Micro Medical Solution, Inc.
Contact Kate Mandall
Phone (949) 292-5466
Email kmandall@micromedicalsolutions.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This prospective pivotal study is a double arm, randomized multi-center study evaluating the safety and performance of the MicroStent peripheral vascular stent system for use in arterial lesions below the knee. A total of 177 subjects will be enrolled at up to 25 centers and followed for up to 3 years, with the primary safety and efficacy endpoints evaluated 30 days and 6 months, respectively, post-implant.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 177
Est. completion date August 2021
Est. primary completion date January 2021
Accepts healthy volunteers No
Gender All
Age group 21 Years to 90 Years
Eligibility General Inclusion Criteria:

1. Subject is a male or a non-pregnant female adult between the age of 21 and 90 years old.

2. Subject has documented clinical evidence of critical limb ischemia (CLI) in the target limb prior to the index procedure, with a Rutherford Classification score of 4-5.

3. The subject, or subject's designated legal representative, has been informed of the nature of the study and is willing to provide written informed consent.

4. Subject is willing to comply with all required follow-up visits.

5. Subject life expectancy is =1 year per the Principal Investigator.

Angiographic Inclusion Criteria:

6. Target vessel reconstitutes at or above the ankle with inline flow to at least one patent (<50% stenosis) inframalleolar outflow vessel.

7. Subject has a lesion, with = 70% stenosis and = 12.0 cm in length located at or distal to the tibial-peroneal trunk and above the tibiotalar joint; including the anterior tibial, posterior tibial or peroneal arteries.

8. Target lesion has a reference vessel diameter of 2.5 - 4.5 mm

9. The target lesion is able to be crossed with a guidewire to facilitate treatment with the randomized device.

General Exclusion Criteria:

1. Subject had a prior or has a planned index limb amputation above the ankle.

2. Subject has a wound/ulcer on the forefoot with a surface area >4cm² or osteomyelitis involving the calcaneus bone.

3. Subject is pregnant, plans to become pregnant, or is nursing.

4. Subject has clinical conditions that severely inhibit X-ray or duplex ultrasound visualization (e.g. body habitus).

5. Subject has a history of hypercoagulation/clotting disorders or acute thrombosis.

6. Subject has allergy to iodinated contrast media that cannot be adequately managed with medication.

7. Subject is in acute renal failure.

8. Subject has an active systemic infection.

9. Subject is participating in another research study involving an investigational device, biologic, or drug that has not completed the primary endpoint at the time of randomization/enrollment.

10. Subject has other comorbidities that - in the opinion of the investigator - preclude them from receiving study treatment and/or from completing the required study follow-up assessments.

11. Subject presents with acute limb ischemia or acute thrombosis of the target limb.

12. Subject has experienced myocardial infarction, thrombolysis, or angina less than 30 days prior to the index procedure.

13. Subject had a stroke within 3 months of index procedure.

Angiographic Exclusion Criteria:

14. Failure to successfully treat clinically significant inflow lesions in the ipsilateral iliac, femoral, or popliteal arteries. Successful treatment is defined as obtaining =30% residual stenosis with no major procedural complications (e.g embolism).

15. Failure to successfully treat significant non-target infra-popliteal lesions. Successful treatment is defined as obtaining =30% residual stenosis with no major procedural complications (e.g. embolism).

16. Target lesion is within a previously placed stent.

Study Design


Intervention

Device:
MicroStent or percutaneous transluminal angioplasty (PTA)
Intravascular treatment

Locations

Country Name City State
United States University of Maryland Medical Center Baltimore Maryland
United States Cardiovascular Associates of the Southeast Birmingham Alabama
United States Deborah Heart and Lung Center Browns Mills New Jersey
United States Rush University Medical Center Chicago Illinois
United States North Jersey Vascular Center Clifton New Jersey
United States Ohio Health Riverside Methodist Columbus Ohio
United States Midwest Cardiovascular Research Foundation Davenport Iowa
United States Advanced Cardiac and Vascular Amputation Prevention Center Grand Rapids Michigan
United States Cardiovascular Institute of the South Houma Louisiana
United States First Coast Cardiovascular Institute Jacksonville Florida
United States Premier Vascular Access and Imaging Center Knoxville Tennessee
United States AZH/WAVE Vascular Center Milwaukee Wisconsin
United States New York University - Langone Health New York New York
United States Einstein Heart and Vascular Philadelphia Pennsylvania
United States Rhode Island Hospital Providence Rhode Island
United States NC Heart and Vascular Research Raleigh North Carolina
United States Eastlake Cardiovascular Roseville Michigan
United States Advent Health Sebring Sebring Florida
United States Cardiovascular Associates of East Texas Tyler Texas

Sponsors (1)

Lead Sponsor Collaborator
Micro Medical Solution, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Freedom from perioperative death (POD) Primary Safety Endpoint 30 days post index procedure
Primary Freedom from major adverse limb event (MALE) Primary Safety Endpoint 6 months post index procedure
Primary Freedom from major amputation Primary Effectiveness Endpoint 6 months post index procedure
Primary Freedom from target lesion occlusion with no clinically driven target lesion reintervention (TLR) Primary Effectiveness Endpoint 6 months post index procedure
Secondary Freedom from major adverse limb event (MALE) Secondary Safety Endpoint #1 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post index procedure
Secondary Frequency and severity of serious adverse events and device and procedure-related adverse events. Secondary Safety Endpoint #2 Post randomization, 30 days, 3 months, 6 months, 1 year, 2 year, and 3 years post randomization
Secondary Freedom from major amputation (above the ankle) Secondary Effectiveness Endpoint #1 6 months post index procedure
Secondary Reduction in size of ischemic leg/foot ulcers Secondary Effectiveness Endpoint #2 6 months post index procedure
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