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

NCT02942966 | Completed Results DMC FDA Device

• 1 other identifier: CA 0137
• Study Type: interventional
• Target: 233
• Locations: 6 countries
• Sites: 49

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

Keywords

Angioplasty; Below the Knee; PAD; Critical Limb Ischemia; Lesion; Claudication

Outcome Measures

Primary Outcomes (2)

• Efficacy - Number of Participants With Freedom From MALE at 6 Months and POD at 30 Days

  Freedom from major adverse limb events (MALE) at 6 months defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death (POD) at 30 days.

  6 months

• Safety - Number of Participants With MALE Plus POD at 30 Days

  Major adverse limb events (MALE) at 30 days defined as above-ankle target limb amputation or major re-intervention to the target lesion(s) (i.e. new bypass graft, jump/interposition graft revision, or thrombectomy / thrombolysis) and perioperative death at 30 days

  30 days

Secondary Outcomes (2)

• Patency - Number of Target Lesion(s) Tacked Segment(s) Patent at 6 Months

  6 months

• Target Limb Salvage - Number of Participants With Freedom From Above-Ankle Target Limb Amputation at 6 Months

  6 months

Study Arms (1)

Tack Implant

EXPERIMENTAL

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

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:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Philips Clinical & Medical Affairs Global: lead

Study Sites (49)

Yuma Regional Medical Center

Yuma, Arizona, 85364, United States

Location

Mission Cardiovascular Research Institute

Fremont, California, 94538, 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

First Coast Cardiovascular Institute

Jacksonville, Florida, 32256, United States

Location

Piedmont Heart Institute

Atlanta, Georgia, 30309, United States

Location

Amita Health Cardiovascular Associates

Elk Grove Village, Illinois, 60007, United States

Location

Advocate Christ Medical Center

Oak Lawn, Illinois, 60453, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52803, United States

Location

Cardiovascular Institute of the South

Houma, Louisiana, 70360, United States

Location

Ascension St. John Hospital

Detroit, Michigan, 48215, United States

Location

Michigan Vascular Center

Flint, Michigan, 48507, United States

Location

St. Louis Heart & Vascular

St Louis, Missouri, 63136, United States

Location

Deborah Heart and Lung Center

Browns Mills, New Jersey, 08015, 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

Novant Health Heart and Vascular Institute

Matthews, North Carolina, 28204, United States

Location

Rex Hospital

Raleigh, North Carolina, 27607, United States

Location

WakeMed Hospital

Raleigh, North Carolina, 27609, United States

Location

Lindner Research Center

Cincinnati, Ohio, 45219, United States

Location

University Hospitals, Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

Ohio Health Research Institute

Columbus, Ohio, 43214, United States

Location

Einstein Healthcare Network

Philadelphia, Pennsylvania, 19141, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Palmetto Health USC Medical Group

Columbia, South Carolina, 29203, United States

Location

Kore Cardiovascular Research

Jackson, Tennessee, 38305, United States

Location

Centennial Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Texas Medical Branch at Galveston

Galveston, Texas, 77555, United States

Location

Baylor College of Medicine

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

The Heart Hospital Baylor Plano

Plano, Texas, 75093, United States

Location

Cardiovascular Associates of East Texas

Tyler, Texas, 75701, United States

Location

Sentara Vascular Specialists

Norfolk, Virginia, 23507, United States

Location

Lake Washington Vascular, PLLC

Bellevue, Washington, 98004, United States

Location

Division of Angiology, Medical University Graz

Graz, 8036, Austria

Location

St. Anne's University Hospital Brno

Brno, Czechia

Location

Karolinen-Hospital

Arnsberg, 59759, Germany

Location

Franziskus-Hospital Berlin-Radiology

Berlin, 10787, Germany

Location

Westküstenklinikum Heide

Heide, 25746, Germany

Location

Universitätsklinikum Leipzig

Leipzig, 04103, Germany

Location

Evangelisches Krankenhaus Mülheim an der Ruhr

Mülheim, Germany

Location

Krankenhaus Buchholz

Nordheide, 21244, Germany

Location

MEDINOS Kliniken des Landkreises Sonneberg GmbH

Sonneberg, 96515, Germany

Location

Heart & Vascular Center - Semmelweis University

Budapest, 1122, Hungary

Location

Bács-Kiskun County Hospital

Kecskemét, Hungary

Location

Auckland Hospital

Auckland, 1023, New Zealand

Location

Related Publications (4)

• 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.

  PMID: 19897335 BACKGROUND

• 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.

  PMID: 24126108 BACKGROUND

• 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.

  PMID: 35352604 DERIVED

• 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.

  PMID: 35156451 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Nicolas Aguirre
• Organization: Philips Image Guided Therapy

nicolas.aguirre@philips.com

(612) 297-6655

Study Officials

• Patrick J. Geraghty, MD

  Washington University School of Medicine in St. Louis

  PRINCIPAL INVESTIGATOR

• George Adams, MD

  Rex Hospital

  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: October 20, 2016
• First Posted: October 24, 2016
• Study Start: February 8, 2017
• Primary Completion: July 11, 2019
• Study Completion: January 10, 2022
• Last Updated: January 31, 2022
• Results First Posted: July 28, 2021

Record last verified: 2021-04

Locations

AU (1); CZ (1); HU (2); US (37); DE (7); NZ (1)