Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries

NCT ID: NCT02942966

Last Updated: 2022-01-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 233 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-02-08
• Study Completion Date: 2022-01-10

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 the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter from 1.5mm to 4.5mm for the treatment of post percutaneous transluminal balloon angioplasty (PTA) dissection(s) requiring repair.

Conditions

Peripheral Arterial Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tack Implant

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

Group Type: EXPERIMENTAL

Tack Endovascular System

Intervention Type: DEVICE

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

Interventions

Tack Endovascular System

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

Intervention Type: DEVICE

Other Intervention Names

Post-PTA Dissection Repair Implant; Tack Implant; Tack Dissection Repair Device

Eligibility Criteria

Inclusion Criteria

• Males or non-pregnant females ≥ 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 (abstinence is acceptable) through the duration of the study
• Subject 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 (ICF), an impartial witness may sign on behalf of the subject
• Willing to comply with all required follow-up visits
• Rutherford Classification 4 or 5.
• WIfI Wound grade of 0, 1 or modified 2.
• WIfI Foot Infection grade of 0 or 1.
• Estimated life expectancy ≥1 year

Exclusion Criteria

• Is pregnant or refuses to use contraception through the duration of the study
• Previous bypass graft in the target limb
• Acute limb ischemia, defined as symptom onset occurring less than 14 days prior to the index procedure
• Prior or planned above-ankle amputation or complete transmetatarsal amputation to the target limb (this does not apply to ray amputation of ≤2 digits, simple digital amputations or ulcer debridements)
• WIfI Foot Infection grade 2 or 3
• Any systemic infection or immunocompromised state. Patients with an ascending infection/deep foot infection or abscess/white blood count (WBC)≥12,000/or febrile state
• Endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) to the target limb less than 30 days prior to or planned for less than 30 days after the index procedure
• Existing stent implant in the target vessel
• Any other endovascular or surgical procedure (not including diagnostic procedures, planned simple digital amputation or wound debridement) less than 14 days prior to the index procedure or planned procedure less than 30 days after 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
• WIfI Wound grade of 2 or 3.
• Any subject in which antiplatelet, anticoagulant, or thrombolytic therapy is contraindicated
• Myocardial infarction, coronary thrombolysis or angina less than 30 days prior to the Index Procedure
• History of stroke or transient ischemic attack (TIA) less than 90 days prior to the Index Procedure
• Currently on dialysis
• Known hypersensitivity or contraindication to nickel-titanium alloy (Nitinol)
• Participating in another ongoing investigational clinical trial in which the subject has not completed the primary endpoint(s)
• Has other comorbidities that, in the opinion of the investigator, would preclude them from receiving this treatment and/or participating in study-required follow-up assessments
• Known hypersensitivity or allergy to contrast agents that cannot be medically managed
• Subject already enrolled into this study
• Restenotic target lesion previously treated by means other than plain balloon angioplasty and/or less than 1 year prior to index procedure.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Philips Clinical & Medical Affairs Global

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Patrick J. Geraghty, MD

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine in St. Louis

George Adams, MD

Role: PRINCIPAL_INVESTIGATOR

Rex Hospital

Locations

Yuma Regional Medical Center

Yuma, Arizona, United States

Mission Cardiovascular Research Institute

Fremont, California, United States

Denver VA Medical Center

Denver, Colorado, United States

Yale New Haven Hospital

New Haven, Connecticut, United States

MedStar Washington Hospital Center

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

First Coast Cardiovascular Institute

Jacksonville, Florida, United States

Piedmont Heart Institute

Atlanta, Georgia, United States

Amita Health Cardiovascular Associates

Elk Grove Village, Illinois, United States

Advocate Christ Medical Center

Oak Lawn, Illinois, United States

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Cardiovascular Institute of the South

Houma, Louisiana, United States

Ascension St. John Hospital

Detroit, Michigan, United States

Michigan Vascular Center

Flint, Michigan, United States

St. Louis Heart & Vascular

St Louis, Missouri, United States

Deborah Heart and Lung Center

Browns Mills, New Jersey, United States

Holy Name Medical Center

Teaneck, New Jersey, United States

New Mexico Heart Institute, PA

Albuquerque, New Mexico, United States

Novant Health Heart and Vascular Institute

Matthews, North Carolina, United States

Rex Hospital

Raleigh, North Carolina, United States

WakeMed Hospital

Raleigh, North Carolina, United States

Lindner Research Center

Cincinnati, Ohio, United States

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, United States

Ohio Health Research Institute

Columbus, Ohio, United States

Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, United States

The Miriam Hospital

Providence, Rhode Island, United States

Palmetto Health USC Medical Group

Columbia, South Carolina, United States

Kore Cardiovascular Research

Jackson, Tennessee, United States

Centennial Medical Center

Nashville, Tennessee, United States

University of Texas Medical Branch at Galveston

Galveston, Texas, United States

Baylor College of Medicine

Houston, Texas, United States

North Dallas Research Associates

McKinney, Texas, United States

Mission Research Institute

New Braunfels, Texas, United States

The Heart Hospital Baylor Plano

Plano, Texas, United States

Cardiovascular Associates of East Texas

Tyler, Texas, United States

Sentara Vascular Specialists

Norfolk, Virginia, United States

Lake Washington Vascular, PLLC

Bellevue, Washington, United States

Division of Angiology, Medical University Graz

Graz, , Austria

St. Anne's University Hospital Brno

Brno, , Czechia

Karolinen-Hospital

Arnsberg, , Germany

Franziskus-Hospital Berlin-Radiology

Berlin, , Germany

Westküstenklinikum Heide

Heide, , Germany

Universitätsklinikum Leipzig

Leipzig, , Germany

Evangelisches Krankenhaus Mülheim an der Ruhr

Mülheim, , Germany

Krankenhaus Buchholz

Nordheide, , Germany

MEDINOS Kliniken des Landkreises Sonneberg GmbH

Sonneberg, , Germany

Heart & Vascular Center - Semmelweis University

Budapest, , Hungary

Bács-Kiskun County Hospital

Kecskemét, , Hungary

Auckland Hospital

Auckland, , New Zealand

Countries

United States; Austria; Czechia; Germany; Hungary; New Zealand

References

Conte MS, Geraghty PJ, Bradbury AW, Hevelone ND, Lipsitz SR, Moneta GL, Nehler MR, Powell RJ, Sidawy AN. Suggested objective performance goals and clinical trial design for evaluating catheter-based treatment of critical limb ischemia. J Vasc Surg. 2009 Dec;50(6):1462-73.e1-3. doi: 10.1016/j.jvs.2009.09.044. Epub 2009 Nov 7.

Reference Type: BACKGROUND

PMID: 19897335 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24126108 (View on PubMed)

Adams GL, Lichtenberg M, Wissgott C, Schmidt A, Tarra T, Matricardi S, Geraghty PJ. Twenty-Four Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries. J Endovasc Ther. 2023 Jun;30(3):393-400. doi: 10.1177/15266028221083462. Epub 2022 Mar 30.

Reference Type: DERIVED

PMID: 35352604 (View on PubMed)

Geraghty PJ, Adams GL, Schmidt A, Lichtenberg M, Wissgott C, Armstrong EJ, Hertting K; TOBA II BTK investigators. Twelve-Month Results of Tack-Optimized Balloon Angioplasty Using the Tack Endovascular System in Below-the-Knee Arteries (TOBA II BTK). J Endovasc Ther. 2020 Aug;27(4):626-636. doi: 10.1177/1526602820944402.

Reference Type: DERIVED

PMID: 35156451 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

CA 0137

Identifier Type: -

Identifier Source: org_study_id