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Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
NA trial testing Tack Endovascular System in Peripheral Arterial Disease in 233 participants. Completed in 10 January 2022.
| Lead sponsor | Philips Clinical & Medical Affairs Global |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 233 |
| Start date | 8 February 2017 |
| Primary completion | 11 July 2019 |
| Estimated completion | 10 January 2022 |
| Sites | 49 locations across New Zealand, Austria, Germany, Hungary, United States, Czechia |
Philips Clinical & Medical Affairs Global — full company profile →
18 and older, any sex, with Peripheral Arterial Disease. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
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.
| Group | Value | 95% CI |
|---|---|---|
| Tack Endovascular System (4F) | 200 |
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
| Group | Value | 95% CI |
|---|---|---|
| Tack Endovascular System (4F) | 3 |
Target lesion(s) tacked segment(s) patency at 6 months defined as the presence of blood flow using duplex ultrasound. If angiography is available within the 6 month follow-up visit window, it should be used in place of the duplex ultrasound. Evidence of no blood flow within the Tacked segment indicates restenosis/loss of patency.
| Group | Value | 95% CI |
|---|---|---|
| Tack Endovascular System (4F) | 248 |
Target Limb Salvage defined as freedom from any above-ankle target limb amputation at 6 months.
| Group | Value | 95% CI |
|---|---|---|
| Tack Endovascular System (4F) | 206 |
Time frame: Summary of adverse events that have been reported through 210 days. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Tack Endovascular System (… |
|---|---|---|
| Peripheral vascular disease | Vascular disorders | — |
| Claudication | Vascular disorders | — |
| Gangrene toe | Infections and infestations | — |
| Anemia | Blood and lymphatic system disorders | — |
| Osteomyelitis of the foot | Infections and infestations | — |
| Pneumonia, organism unspecified | Infections and infestations | — |
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | — |
| Peripheral artery restenosis | Injury, poisoning and procedural complications | — |
| Acute renal failure | Renal and urinary disorders | — |
| Peripheral arterial occlusive disease aggravated | Vascular disorders | — |
| Decompensation cardiac | Cardiac disorders | — |
| Non ST segment elevation myocardial infarction | Cardiac disorders | — |
| In-stent peripheral artery restenosis | General disorders | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Critical limb ischemia | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Acute on chronic heart failure | Cardiac disorders | — |
| Aortic valve stenosis | Cardiac disorders | — |
| Congestive heart failure | Cardiac disorders | — |
| Heart failure | Cardiac disorders | — |
| Heart insufficiency | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Chest pain | General disorders | — |
| Delayed healing of wound | General disorders | — |
| Reaction | System | Tack Endovascular System (… |
|---|---|---|
| Peripheral artery restenosis | Injury, poisoning and procedural complications | — |
| Peripheral vascular disease | Vascular disorders | — |
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | — |
| Claudication | Vascular disorders | — |
| Gangrene toe | Infections and infestations | — |
| Pseudoaneurysm | Injury, poisoning and procedural complications | — |
| Peripheral arterial occlusive disease aggravated | Vascular disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Osteomyelitis of the foot | Infections and infestations | — |
| Pneumonia, organism unspecified | Infections and infestations | — |
| Post procedural complication | Injury, poisoning and procedural complications | — |
| Acute renal failure | Renal and urinary disorders | — |
| Decompensation cardiac | Cardiac disorders | — |
| Non ST segment elevation myocardial infarction | Cardiac disorders | — |
| Delayed healing of wound | General disorders | — |
| In-stent peripheral artery restenosis | General disorders | — |
| Gangrene peripheral | Infections and infestations | — |
| Post procedural hematoma | Injury, poisoning and procedural complications | — |
| Wound | Injury, poisoning and procedural complications | — |
| Hyperglycemia | Metabolism and nutrition disorders | — |
| Acute kidney injury | Renal and urinary disorders | — |
| Critical limb ischemia | Vascular disorders | — |
| Digital necrosis | Vascular disorders | — |
| Hypotension | Vascular disorders | — |
| Acute on chronic heart failure | Cardiac disorders | — |
| Aortic valve stenosis | Cardiac disorders | — |
| Congestive heart failure | Cardiac disorders | — |
| Heart failure | Cardiac disorders | — |
| Heart insufficiency | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Gastrointestinal bleeding | Gastrointestinal disorders | — |
| Melena | Gastrointestinal disorders | — |
| Chest pain | General disorders | — |
| Leg edema | General disorders | — |
| Sepsis | Infections and infestations | — |
| Vascular access site hematoma | Injury, poisoning and procedural complications | — |
| Leg pain | Musculoskeletal and connective tissue disorders | — |
| Carotid artery stenosis | Nervous system disorders | — |
| Stroke | Nervous system disorders | — |
| Acute on chronic renal failure | Renal and urinary disorders | — |
Most-reported serious reactions: Peripheral vascular disease, Claudication, Gangrene toe, Anemia, Osteomyelitis of the foot, Pneumonia, organism unspecified, Peripheral arterial reocclusion, Peripheral artery restenosis.
Data from ClinicalTrials.gov NCT02942966 adverse events section.
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.
6 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02942966.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing