Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System™ in Femoropoliteal Arteries

NCT02522884 | Completed Results DMC

• 1 other identifier: CA 0119
• Study Type: interventional
• Target: 213
• Locations: 3 countries
• Sites: 39

Brief Summary

This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in subjects with post-balloon angioplasty (post-PTA) dissection(s) type(s) A through F in the superficial femoral and proximal popliteal arteries ranging in diameter from 2.5mm to 6.0mm.

Conditions

Peripheral Artery Disease

Keywords

Angioplasty; Peripheral Artery Disease; PAD; Lesion; Claudication

Outcome Measures

Primary Outcomes (2)

• Efficacy - Number of Subjects That Met Primary Patency Criteria at 12 Months

  Primary patency defined as freedom from Clinical Events Committee (CEC) adjudicated clinically-driven target lesion revascularization (CD-TLR) and freedom from core lab adjudicated duplex ultrasound derived binary restenosis at 12 months (defined as peak systolic velocity ratio (PSVR) \>2.5)

  12 Months

• Safety - Number of Subjects That Met the Primary Safety Criteria of Freedom From Major Adverse Events at 30 Days

  Freedom from the occurrence of any new-onset major adverse event(s) (MAEs) defined as index limb amputation (above the ankle), CEC adjudicated clinically-driven target lesion revascularization (CD-TLR), or all-cause death at 30 days.

  30 Days

Study Arms (1)

Tack Implant

EXPERIMENTAL

Implantation of a Tack using the Intact Vascular Tack Endovascular System for the repair of post angioplasty dissections.

Device: Tack Endovascular System

Interventions

Tack Endovascular System DEVICE

Repair of post-PTA dissections using the Intact Vascular Tack Endovascular System.

Also known as: Post-PTA Dissection Repair Implant, Tack Implant, Tack Dissection Repair Device

Tack Implant

Eligibility Criteria

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

You may qualify if:

• Male or non-pregnant Female ≥ 18 years of age at the time of consent
• Female subjects of childbearing potential must have a negative pregnancy test prior to treatment and must use some form of contraception through the duration of the study (abstinence is acceptable)
• Target limb requires no additional treatment aside from the target lesion and the iliac artery(ies) during the index procedure
• Subject or has been informed of and understands the nature of the study and provides signed informed consent to participate in the study. If the subject possesses the ability to understand and provide informed consent but due to physical inability, the subject cannot sign the Informed Consent Form, an impartial witness may sign on behalf of the subject
• Willing to comply with all required follow-up visits
• Rutherford Classification 2, 3 or 4
• Estimated life expectancy \>1 year
• Eligible for standard surgical repair, if necessary
• Subject is ambulatory (assistive devices such as a cane or walker is acceptable)

You may not qualify if:

• Rutherford Classification 0, 1, 5 or 6
• Is pregnant or refuses to use contraception through the duration of the study
• Previous infrainguinal bypass graft in the target limb
• Planned amputation on the target limb
• Systemic infection or Infection within the target limb and/or immunocompromised
• Endovascular or surgical procedure (not including diagnostic procedures) on the target limb within 30 days prior to or within 30 days after the index procedure
• Endovascular or surgical procedure (not including diagnostic procedures) on the non-target limb within 14 days prior to the index procedure or planned procedure within 30 days after the index procedure
• Prior coronary artery bypass graft (CABG) or percutaneous coronary intervention (PCI) procedure within 30 days prior to the index procedure or planned CABG/PCI within 30 days after the index procedure
• Any other previous or planned surgical or endovascular procedure (not including diagnostic procedures) within 14 days prior to or 30 days post index procedure
• Planned atherectomy, cryoplasty, stenting or any other treatment (with the exception of a crossing device) of the target lesion other than PTA during the index procedure
• Known coagulopathy, hypercoagulable state, bleeding diathesis, other blood disorder, or a platelet count less than 80,000/microliter or greater than 500,000/microliter
• Known hypersensitivity or allergy to antiplatelet or anticoagulant therapy
• Myocardial infarction within 30 days prior to enrollment
• History of stroke within 90 days prior to enrollment
• Serum creatinine of \>2.5 mg/dL

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (39)

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Central Arkansas Veteran's Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Cedars Sinai Medical Center

Beverly Hills, California, 90211, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, United States

Location

St. Joseph Hospital

Orange, California, 92868, United States

Location

Denver VA Medical Center

Denver, Colorado, 80220, United States

Location

Yale New Haven Hospital

New Haven, Connecticut, 06510, United States

Location

MedStar Washington Hospital Center

Washington D.C., District of Columbia, 20010, United States

Location

Florida Research Network, LLC

Gainesville, Florida, 32605, United States

Location

Alexian Brothers Medical Center Heart & Vascular Institute

Elk Grove Village, Illinois, 60007, United States

Location

Adventist Midwest Health

LaGrange, Illinois, 60439, United States

Location

Prairie Education and Research Cooperative

Springfield, Illinois, 62701, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

University of Iowa

Iowa City, Iowa, 52242, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66226, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Metro Health Hospital

Wyoming, Michigan, 49519, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

New Mexico Heart Institute, PA

Albuquerque, New Mexico, 87102, United States

Location

NC Heart and Vascular Research

Raleigh, North Carolina, 27607, United States

Location

NC Heart and Vascular Research - WakeMed Raleigh

Raleigh, North Carolina, 27610, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Holy Spirit Cardiology

Camp Hill, Pennsylvania, 17011, United States

Location

St. Mary Medical Center

Langhorne, Pennsylvania, 19047, United States

Location

Einstein Medical Center Philadelphia

Philadelphia, Pennsylvania, 19141, United States

Location

Pinnacle Health Cardiovascular Institute

Wormleysburg, Pennsylvania, 17043, United States

Location

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

North Central Heart

Sioux Falls, South Dakota, 57108, United States

Location

Wellmont CVA Heart Institute

Kingsport, Tennessee, 37660, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

The University of Texas Health Science Center at Houston

Houston, Texas, 77030, United States

Location

North Dallas Research Associates

McKinney, Texas, 75069, United States

Location

Mission Research Institute

New Braunfels, Texas, 78130, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Medical University Hospital Graz

Graz, Austria

Location

Hanusch Krankenhaus

Vienna, Austria

Location

St. Antonius Hospital

Nieuwegein, Utrecht, Netherlands

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Intermittent Claudication

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Joseph C. Griffin, III
• Organization: Intact Vascular, Inc.

JGriffin@intactvascular.com

4842531048

Study Officials

• William A. Gray, MD

  Main Line Health/Lankenau Heart Institute

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

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

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: September 1, 2015
• Primary Completion: May 1, 2018
• Study Completion: March 1, 2020
• Last Updated: April 27, 2021
• Results First Posted: December 10, 2019

Record last verified: 2021-04

Locations

US (36); AU (2); NL (1)