Tack Optimized Balloon Angioplasty Post-Market Study (TOBA PMS)

The objective of this study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.

Study Overview

• Status: Recruiting
• Conditions: Peripheral Arterial Disease; Peripheral Vascular Diseases; PAD; PAD - Peripheral Arterial Disease; Dissection; Arterial Dissection
• Intervention / Treatment: Device: The Tack Endovascular System

Detailed Description

The purpose of this post-market study is to obtain outcomes following dissection repair with the Tack Endovascular System in a broad population of patients undergoing endovascular treatment of lesions within the superficial femoral, popliteal, peroneal, and/or tibial arteries.

The Tack Endovascular System has been shown to effectively repair dissection and improve outcomes in clinical studies. Additional data, such as clinical utility of the Tack Endovascular System with the combined use of adjunctive therapies - other than balloon angioplasty alone, is needed.

Patients with claudication or CLI, who meet Rutherford classification 3, 4, or 5 criteria if ATK and Rutherford classification criteria 4 or 5 if BTK, who have undergone an above the knee (ATK) or below the knee (BTK) endovascular procedure utilizing adjunctive therapies other than balloon angioplasty alone which are then followed by PTA and IVUS, and have an arterial dissection requiring repair.

Approximately 100 subjects will be enrolled in up to 10 sites. The enrollment will be capped as follows:

• ATK: 50% of subjects
• BTK: 50% of subjects

After enrollment of planned 100 subjects and interim analysis, the study may enroll up to 200 additional subjects at up to 20 additional sites, with each site limited to 15% of total enrollment.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Alicia Sherwin; Phone Number: (610) 368-7142; Email: toba.pms@philips.com

Study Locations

• United States
  • Colorado
    • Thornton, Colorado, United States, 80023
      • Not yet recruiting
      • Advanced Heart and Vein Center - Thornton
      • Contact: ClinRe; Phone Number: 917-499-5115; Email: crc@clinre.com
      • Principal Investigator: Ehrin Armstrong
  • Connecticut
    • Hartford, Connecticut, United States, 06106
      • Recruiting
      • Hartford Hospital
      • Contact: Alison Champagne; Email: Alison.Champagne@hhchealth.org
      • Principal Investigator: Edward Gifford
  • Florida
    • Fort Lauderdale, Florida, United States, 33312
      • Recruiting
      • Palm Vascular Center Research
      • Contact: Jennifer Gimeno; Phone Number: 305-763-8734; Email: jennifer@palmvascular.com
      • Principal Investigator: Robert Beasley
  • Indiana
    • Munster, Indiana, United States, 46321
      • Recruiting
      • Munster Medical Research Foundation
      • Contact: Tera Gagne; Email: Tera.M.Gagne@comhs.org
      • Principal Investigator: David Stewart
  • New Jersey
    • Flemington, New Jersey, United States, 08822
      • Recruiting
      • Advanced Heart and Vascular Institute of Hunterdon
      • Contact: Meghan Sheehan; Email: msheehan@ahvi-nj.com
      • Principal Investigator: Andrey Espinoza
    • Hackensack, New Jersey, United States, 07601
      • Not yet recruiting
      • Hackensack University Medical Center
      • Contact: Stephanie Lynes; Phone Number: 551-996-5595; Email: stephanie.lynes@hmhn.org
      • Principal Investigator: David O'Connor, MD
  • Oklahoma
    • Bartlesville, Oklahoma, United States, 74006
      • Not yet recruiting
      • Ascension St. John Heart and Vascular Center
      • Contact: Mary Harris; Email: mary.harris@ascension.org
      • Principal Investigator: Anderson P Mehrle, MD
  • Rhode Island
    • Providence, Rhode Island, United States, 02906
      • Recruiting
      • The Miriam Hospital
      • Principal Investigator: Peter Soukas
      • Contact: Lina Felix; Email: LFelix@Lifespan.org
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • University of Texas Southwestern Medical Center
      • Contact: Jarrett Hubbard; Phone Number: 214-648-7200; Email: jarrett.hubbard@utsouthwestern.edu
      • Principal Investigator: Michael Siah
    • McKinney, Texas, United States, 75069
      • Not yet recruiting
      • North Dallas Research Associates
      • Contact: Samina Ahsanullah; Phone Number: 259 972-529-6939; Email: samina@ndresearch.com
      • Contact: Phone Number: 469-288-7751
      • Principal Investigator: Muhammad A Khan, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Subjects with claudication (Rutherford 3) or CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. ATK lesions will be in the superficial femoral and/or proximal popliteal arteries; BTK lesions will be in the mid/distal popliteal, peroneal and/or tibial arteries. To be enrolled, subjects must meet all inclusion criteria and not meet any of the exclusion criteria.

Description

Inclusion Criteria:

General Inclusion Criteria

1. Age ≥ 18 years
2. Willingness to comply with study follow-up evaluations at the predefined time intervals
3. Signs the written informed consent

4. Meets Rutherford classification criteria:

   1. ATK subjects can be RCC 3, 4 or 5
   2. BTK subjects must be RCC 4 or 5

Angiographic Inclusion Criteria

1. A de novo or restenotic, non-stented target lesion with pre-intervention stenosis or occlusion (by visual estimate)

2. ATK Lesions:

   1. must be in the superficial femoral and/or proximal popliteal (P1) arteries and
   2. have a reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm.

3. BTK Lesions:

   1. must be in the mid/distal popliteal (P2/P3), peroneal and/or tibial arteries and
   2. have a reference vessel diameter range of 1.5-4.5mm Note: The mid popliteal artery begins at the superior aspect of the patella.

Post-IVUS Inclusion Criteria

1. Presence of an arterial dissection requiring repair per investigator judgement
2. ATK reference vessel diameter range of 3.5-6.0mm or 4.0-8.0mm
3. BTK reference vessel diameter range of 1.5-4.5mm

Exclusion Criteria:

General Exclusion Criteria

1. Subject is known to be breastfeeding, pregnant or planning to become pregnant during the study
2. Anticipated life expectancy < 12 months
3. Known COVID positive test within 14 days and active symptoms
4. Known renal disease that precludes contrast administration
5. Presence of a wound that in the opinion of the investigator cannot be healed with transmetatarsal amputation (TMA)
6. Contraindication to anticoagulation and/or antiplatelet therapy
7. Known allergy to nitinol (nickel and/or titanium)
8. Known allergy to contrast media that cannot be adequately pre-medicated prior to index procedure

9. Previous or planned surgical or interventional procedure within 3 days before or 30 days after the index procedure.

   Note: this excludes successful inflow artery treatment within the same hospitalization or a documented pre-planned minor amputation.

10. Subject has any condition that in the opinion of the investigator precludes the subject from participation

Angiographic Exclusion Criteria

1. Residual diameter stenosis ≥30% (visual estimate) after PTA
2. Aneurysm, acute or sub-acute thrombosis in target lesion
3. Acute vessel occlusion after PTA not attributed to dissection

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
ATK: Above-The-Knee; Subjects with claudication (Rutherford 3) or CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. ATK subjects will have baseline lesions in the superficial femoral and/or proximal popliteal arteries.	Device: The Tack Endovascular System; The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.
BTK: Below-The-Knee; Subjects with CLTI (Rutherford 4 or 5), who have undergone an endovascular procedure utilizing adjunctive therapies, other than balloon angioplasty alone, which are then followed by PTA and IVUS, and have an arterial dissection requiring repair. BTK subjects will have baseline lesions in the mid/distal popliteal, peroneal and/or tibial arteries.	Device: The Tack Endovascular System; The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Procedure Success	Defined as demonstrated target lesion patency (<30% residual diameter stenosis, by visual estimate) without the use of a bail out stent within the target lesion and without the occurrence of MALE + POD upon completion of the index procedure.	Measured on Day 0 of enrollment, upon completion of the Index Procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Target Lesion Patency - ATK, 6 Months	Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention	6 Months
Target Lesion Patency - ATK, 12 Months	Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention	12 Months
Target Lesion Patency - ATK, 24 Months	Defined as freedom from duplex ultrasound derived binary restenosis (PSVR ≥ 2.5) within the PTA treated segment, without reintervention	24 Months
Target Lesion Patency - BTK, 6 Months	Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention.	6 Months
Target Lesion Patency - BTK, 12 Months	Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention.	12 Months
Target Lesion Patency - BTK, 24 Months	Defined as presence of antegrade blood flow using duplex ultrasound within the PTA treated segment, without reintervention.	24 Months
Death	All cause death	6 months
Death	All cause death	12 months
Death	All cause death	24 months
Major Adverse Limb Events	Rate of MALE	6 months
Major Adverse Limb Events	Rate of MALE	12 months
Major Adverse Limb Events	Rate of MALE	24 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 6 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion.	6 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 6 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	6 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 12 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion.	12 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 12 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	12 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - ATK, 24 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target lesion.	24 months
Freedom from clinically driven target lesion revascularization (CD-TLR) - BTK, 24 Months	TLR is defined as re-treatment by an invasive procedure, including atherectomy, angioplasty, intravascular lithotripsy, stenting, endarterectomy, bypass, or thrombolysis, performed to open or increase the lumen of the target vessel. TLR will be classified as clinically driven or non-clinically driven by the investigator.Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	24 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 6 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel.	6 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 6 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	6 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 12 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel.	12 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 12 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	12 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - ATK, 24 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as PSVR ≥ 2.5 by DUS or if angiography shows >50% diameter stenosis and there are symptoms attributable to increased ischemia or worsening of ABI (defined as deterioration by more than 0.15 from the maximum post-procedural level) that is clearly referable to the target vessel.	24 months
Freedom from clinically driven target vessel revascularization (CD-TVR) - BTK, 24 Months	TVR is defined as a repeat revascularization procedure (percutaneous or surgical) of a lesion in the target vessel, exclusive of the target lesion site. TVR will be classified as clinically driven or non-clinically driven by the investigator. Clinically driven is defined as a restenosis of ≥ 70% in the target vessel with wound persistence, new wounds or reoccurrence of ischemic rest pain.	24 months
Target Limb Salvage	Freedom from above-ankle amputation.	6 months
Target Limb Salvage	Freedom from above-ankle amputation.	12 months
Target Limb Salvage	Freedom from above-ankle amputation.	24 months
Minor Amputation	Freedom from target limb unplanned minor amputation	6 months
Minor Amputation	Freedom from target limb unplanned minor amputation	12 months
Minor Amputation	Freedom from target limb unplanned minor amputation	24 months
Rutherford Classification	Changes from baseline in Rutherford classification	6 months
Rutherford Classification	Changes from baseline in Rutherford classification	12 months
Rutherford Classification	Changes from baseline in Rutherford classification	24 months
Ankle and/or Toe Brachial Index	Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure	6 months
Ankle and/or Toe Brachial Index	Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure	12 months
Ankle and/or Toe Brachial Index	Changes from baseline in target limb Ankle Brachial Index (ABI) and/or Toe Brachial Index (TBI) measurement at post-procedure	24 months
Wound Status	Changes from baseline in target limb wound status	6 months
Wound Status	Changes from baseline in target limb wound status	12 months
Quality of Life / EuroQol EQ-5D-5L	Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	30 Days
Quality of Life / EuroQol EQ-5D-5L	Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	6 months
Quality of Life / EuroQol EQ-5D-5L	Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	12 months
Quality of Life / EuroQol EQ-5D-5L	Changes from baseline in EQ-5D-5L questionnaire. The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state. The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.	24 months
Adverse Events	Device related adverse events (AEs) upon completion of the index procedure	Measured on Day 0 of enrollment, upon completion of the Index Procedure

Collaborators and Investigators

• Sponsor: Spectranetics Corporation

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2023
• Primary Completion (Estimated): February 1, 2025
• Study Completion (Estimated): February 1, 2026

Study Registration Dates

• First Submitted: April 25, 2022
• First Submitted That Met QC Criteria: May 2, 2022
• First Posted (Actual): May 5, 2022

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Atherosclerosis; Aneurysm; Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Dissection, Blood Vessel
• Other Study ID Numbers: IGT-00295

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes