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CVT-SFA First in Human Trial for Treatment of Superficial Femoral Artery or Proximal Popliteal Artery
NA trial testing Peripheral PTA with a drug coated balloon in Femoral Artery Stenosis in 75 participants. Completed in 27 August 2025.
| Lead sponsor | Abbott Medical Devices |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 75 |
| Start date | 17 February 2022 |
| Primary completion | 11 September 2023 |
| Estimated completion | 27 August 2025 |
| Sites | 8 locations across France, Germany |
Abbott Medical Devices — full company profile →
18 and older, any sex, with Femoral Artery Stenosis or Popliteal Artery Stenosis. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Composite rate of cardiovascular death, index limb amputation and ischemia-driven target lesion revascularization (TLR).
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 72 |
Freedom from restenosis as determined by duplex ultrasonography (DUS) (peak systolic velocity ratio (PSVR) ≤2.4 or ≤50% stenosis) and freedom from ischemia-driven target lesion revascularization (TLR).
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 63 |
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR). The time frame for "In hospital" refers to time from procedure to discharge. This timeframe is different for every enrolled subject. The subject is discharged at the treating physician's discretion based on their specific treatment needs.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 0 |
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 1 |
Composite rate of cardiovascular death, index limb amputation and ischemia-driven Target Lesion Revascularization (TLR).
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 67 |
Rate of occurrence arterial thrombosis of the treated segment as determined by QVA
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 0 |
This end point was to asses the Rate of Ipsilateral Embolic Events of the Study Limb.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 2 |
This end point was to asses the Rate of Clinically-driven Revascularization.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 2 |
This end point was to asses the Rate of Clinically-driven Revascularization.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 4 |
The patency results achieved in the CVT-SFA Study translate into meaningful patient benefits as demonstrated by the improvement of secondary outcomes measures.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 61 |
Rate of vascular access site complication defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair or transfusion, prolonged hospital stay, or required a new hospital admission.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 2 |
Lesion success (per device), defined as achievement of a final in-lesion residual diameter stenosis of \<50% (by QA), using any device after wire passage through the lesion. Pre- and post-dilatation of the lesion with a non-study device is considered part of assigned device treatment.
| Group | Value | 95% CI |
|---|---|---|
| Everolimus-coated Balloon | 85 |
Time frame: Baseline to 12 months. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Everolimus-coated Balloon |
|---|---|---|
| Stenosis, non-study limb | General disorders | — |
| Coronary artery disease | Cardiac disorders | — |
| Revascularization | Injury, poisoning and procedural complications | — |
| Terminal cancer | General disorders | — |
| Aneurysm spurium | Injury, poisoning and procedural complications | — |
| Stenosis, non-target lesion | General disorders | — |
| Anemia | Blood and lymphatic system disorders | — |
| Death during heart surgery | Cardiac disorders | — |
| Heart attack | Cardiac disorders | — |
| Partial Infarct | Cardiac disorders | — |
| Right ventricular implant repair | Cardiac disorders | — |
| Colon tumor | Gastrointestinal disorders | — |
| Epigastric pain | Gastrointestinal disorders | — |
| Gastroenteritis | Gastrointestinal disorders | — |
| Inflammatory bladder | Gastrointestinal disorders | — |
| Pancreatitis | Gastrointestinal disorders | — |
| Cancer | General disorders | — |
| Distal embolism | Injury, poisoning and procedural complications | — |
| Spinal contusions | Musculoskeletal and connective tissue disorders | — |
| Spinal stenosis | Musculoskeletal and connective tissue disorders | — |
| Parkinson's Disease | Nervous system disorders | — |
| Stenosis, non-study vessel | General disorders | — |
| Stenosis, target vessel | General disorders | — |
| Cystitis | Renal and urinary disorders | — |
| COPD | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | Everolimus-coated Balloon |
|---|---|---|
| Angiography performed | General disorders | — |
| Stenosis, non-TL | General disorders | — |
| TL occlusion, no action taken | General disorders | — |
| Knee pain | General disorders | — |
| Chest pain | Cardiac disorders | — |
| Calf pain | General disorders | — |
| Leg pain | General disorders | — |
| Allergy to medication | General disorders | — |
| Hip pain | General disorders | — |
| Stenosis, non-study limb | General disorders | — |
| Groin pain | Injury, poisoning and procedural complications | — |
| Groin pain at puncture site | Injury, poisoning and procedural complications | — |
| Hematoma at puncture site | Injury, poisoning and procedural complications | — |
| Back pain | Musculoskeletal and connective tissue disorders | — |
| Hypertriglyceridemia | Blood and lymphatic system disorders | — |
| Arrhythmia | Cardiac disorders | — |
| CRP increase at discharge | Cardiac disorders | — |
| Irregular heartrate | Cardiac disorders | — |
| Thoracic pain | Cardiac disorders | — |
| Burning pain in esophagus | Gastrointestinal disorders | — |
| Esophageal reflux | Gastrointestinal disorders | — |
| Gastroenteritis | Gastrointestinal disorders | — |
| Bruises easily | General disorders | — |
| Bruising/hemotoma over body | General disorders | — |
| Calf claudication | General disorders | — |
| Deep vein thrombosis, non-study limb | General disorders | — |
| Diabetes mellitus II | General disorders | — |
| Distal arteriopathy | General disorders | — |
| Dizzyness | General disorders | — |
| Glaucoma | General disorders | — |
| Groin bleeding | General disorders | — |
| Groin/scrotum hematoma (non-study limb) | General disorders | — |
| Haematoma, right arm | General disorders | — |
| Haematoma, wrist | General disorders | — |
| Knee injury | General disorders | — |
| Leg claudication, non-study limb | General disorders | — |
| Leg oedema, both legs | General disorders | — |
| Lower body/limbs hot | General disorders | — |
| Lower leg swelling | General disorders | — |
| Necrosectomy, heel | General disorders | — |
Most-reported serious reactions: Stenosis, non-study limb, Coronary artery disease, Revascularization, Terminal cancer, Aneurysm spurium, Stenosis, non-target lesion, Anemia, Death during heart surgery.
Data from ClinicalTrials.gov NCT05734157 adverse events section.
The CVT-SFA Trial investigates the inhibition of restenosis using the CVT Everolimus-coated PTA Catheter in the treatment of de-novo occluded/ stenotic or re-occluded/restenotic superficial femoral or popliteal arteries.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Trials by the same sponsor.
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/NCT05734157.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing