Last reviewed · How we verify
Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter)
trial testing Drug Coated Balloon in PAD in 52 participants. Completed in 22 March 2022.
| Lead sponsor | W.L.Gore & Associates |
|---|---|
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 52 |
| Start date | 10 October 2017 |
| Primary completion | 22 March 2022 |
| Estimated completion | 22 March 2022 |
| Sites | 1 location across Germany |
W.L.Gore & Associates — full company profile →
20 and older, any sex, with PAD. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Six month late lumen loss (LLL) is defined as the difference in minimum lumen diameter of the Target lesion between the time points immediately post-intervention and the 6-month follow-up angiography or at the time of a Clinically Driven Target Lesion Revascularization (CD TLR), whichever is earlier.
| Group | Value | 95% CI |
|---|---|---|
| Drug Coated Balloon | -0.17 | ± 0.98 |
A composite 30-day safety endpoint of freedom from Major Adverse Events (MAE), defined as i) death, ii) Clinically-Driven Target Vessel Revascularization (CD TVR), or iii) amputation above the metatarsals, resulting from a vascular event, in the treated leg (Target limb amputation).
| Group | Value | 95% CI |
|---|---|---|
| Drug Coated Balloon | 52 |
Time frame: 2 Years. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | Drug Coated Balloon |
|---|---|---|
| Post angioplasty restenosis | Injury, poisoning and procedural complications | — |
| Atrial fibrillation | Cardiac disorders | — |
| Peripheral arterial reocclusion | Injury, poisoning and procedural complications | — |
| Superficial femoral arterial restenosis | Injury, poisoning and procedural complications | — |
| Femoral artery stenosis | Vascular disorders | — |
| Femoropopliteal stenosis | Vascular disorders | — |
| Iliac artery stenosis | Vascular disorders | — |
| Peripheral artery occlusion | Vascular disorders | — |
| Peripheral artery stenosis | Vascular disorders | — |
| Coagulation disorder | Blood and lymphatic system disorders | — |
| Coronary artery disease | Cardiac disorders | — |
| Mitral valve insufficiency | Cardiac disorders | — |
| Multiple vessel coronary artery disease | Cardiac disorders | — |
| Myocardial infarction | Cardiac disorders | — |
| Non STEMI | Cardiac disorders | — |
| Triple vessel disease | Cardiac disorders | — |
| Cataract (right) | Eye disorders | — |
| Esophagitis ulcerative | Gastrointestinal disorders | — |
| Aspiration pneumonia | Infections and infestations | — |
| Erysipelas | Infections and infestations | — |
| Perineal abscess | Infections and infestations | — |
| Pyelonephritis | Infections and infestations | — |
| Urosepsis | Infections and infestations | — |
| Fracture of pelvis | Injury, poisoning and procedural complications | — |
| Fractured ribs | Injury, poisoning and procedural complications | — |
| Reaction | System | Drug Coated Balloon |
|---|---|---|
| Post angioplasty restenosis | Injury, poisoning and procedural complications | — |
| Superficial femoral arterial restenosis | Injury, poisoning and procedural complications | — |
Most-reported serious reactions: Post angioplasty restenosis, Atrial fibrillation, Peripheral arterial reocclusion, Superficial femoral arterial restenosis, Femoral artery stenosis, Femoropopliteal stenosis, Iliac artery stenosis, Peripheral artery occlusion.
Data from ClinicalTrials.gov NCT02907203 adverse events section.
This study will assess the safety and performance of the Gore drug-coated balloon in the treatment of de novo and restenotic atherosclerotic lesions in the superficial femoral and popliteal arteries of patients with symptomatic PAD.
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
Trials testing the same drug.
Currently open trials in the same condition.
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/NCT02907203.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing