Tack Optimized Balloon Angioplasty Post-Market Study

Peripheral Arterial Disease Clinical Trial

— TOBA PMS  

Official title:

Tack Optimized Balloon Angioplasty Post-Market Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05361967
• Other study ID #: IGT-00295
• Status: Recruiting
• Start date: March 30, 2023
• Est. completion date: February 2026

Study information

• Verified date: February 2024
• Source: Spectranetics Corporation
• Contact: Alicia Sherwin
• Phone: (610) 368-7142
• Email: toba.pms[@]philips.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 2026
• Est. primary completion date: February 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Dissection
• PAD
• PAD - Peripheral Arterial Disease
• Peripheral Arterial Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Device:
• The Tack Endovascular System
The Tack Endovascular System is designed to treat vascular dissections with Tack implant(s) following angioplasty.

Locations

Country	Name	City	State
United States	Ascension St. John Heart and Vascular Center	Bartlesville	Oklahoma
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Advanced Heart and Vascular Institute of Hunterdon	Flemington	New Jersey
United States	Palm Vascular Center Research	Fort Lauderdale	Florida
United States	Hackensack University Medical Center	Hackensack	New Jersey
United States	Hartford Hospital	Hartford	Connecticut
United States	North Dallas Research Associates	McKinney	Texas
United States	Munster Medical Research Foundation	Munster	Indiana
United States	The Miriam Hospital	Providence	Rhode Island
United States	Advanced Heart and Vein Center - Thornton	Thornton	Colorado

Sponsors (1)

Lead Sponsor	Collaborator
Spectranetics Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Death	All cause death	6 months
Secondary	Death	All cause death	12 months
Secondary	Death	All cause death	24 months
Secondary	Major Adverse Limb Events	Rate of MALE	6 months
Secondary	Major Adverse Limb Events	Rate of MALE	12 months
Secondary	Major Adverse Limb Events	Rate of MALE	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Target Limb Salvage	Freedom from above-ankle amputation.	6 months
Secondary	Target Limb Salvage	Freedom from above-ankle amputation.	12 months
Secondary	Target Limb Salvage	Freedom from above-ankle amputation.	24 months
Secondary	Minor Amputation	Freedom from target limb unplanned minor amputation	6 months
Secondary	Minor Amputation	Freedom from target limb unplanned minor amputation	12 months
Secondary	Minor Amputation	Freedom from target limb unplanned minor amputation	24 months
Secondary	Rutherford Classification	Changes from baseline in Rutherford classification	6 months
Secondary	Rutherford Classification	Changes from baseline in Rutherford classification	12 months
Secondary	Rutherford Classification	Changes from baseline in Rutherford classification	24 months
Secondary	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
Secondary	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
Secondary	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
Secondary	Wound Status	Changes from baseline in target limb wound status	6 months
Secondary	Wound Status	Changes from baseline in target limb wound status	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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