Trial Outcomes & Findings for Clinical Investigation of the GORE® Drug-Coated PTA Balloon Catheter (GORE® DCB Catheter) (NCT NCT02907203)
NCT ID: NCT02907203
Last Updated: 2023-02-08
Results Overview
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.
Recruitment status
COMPLETED
Target enrollment
52 participants
Primary outcome timeframe
Six months
Results posted on
2023-02-08
Participant Flow
Participant milestones
| Measure |
Drug Coated Balloon
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
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|---|---|
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Overall Study
STARTED
|
52
|
|
Overall Study
COMPLETED
|
44
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Drug Coated Balloon
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
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|---|---|
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Overall Study
Death
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Surgical bypass
|
1
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Drug Coated Balloon
n=52 Participants
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
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|---|---|
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Age, Continuous
|
69 years
STANDARD_DEVIATION 8.6 • n=52 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=52 Participants
|
|
Sex: Female, Male
Male
|
36 Participants
n=52 Participants
|
|
Region of Enrollment
Germany
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52 participants
n=52 Participants
|
|
Mean Lesion Diameter Post Procedure(mm)
|
4.01 milimeters
STANDARD_DEVIATION 0.69 • n=52 Participants
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PRIMARY outcome
Timeframe: Six monthsPopulation: Of the 44 subjects completed the study, the late lumen loss was only available for 37 subjects, rest were treated as missing data.
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.
Outcome measures
| Measure |
Drug Coated Balloon
n=37 Participants
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
|
|---|---|
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Late Lumen Loss (LLL)
|
-0.17 mm
Standard Deviation 0.98
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SECONDARY outcome
Timeframe: 30 daysA 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).
Outcome measures
| Measure |
Drug Coated Balloon
n=52 Participants
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
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|---|---|
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Number of Subjects With Freedom From Major Adverse Events
|
52 Participants
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Adverse Events
Drug Coated Balloon
Serious events: 27 serious events
Other events: 13 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Drug Coated Balloon
n=52 participants at risk
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
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|---|---|
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Blood and lymphatic system disorders
Coagulation disorder
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1.9%
1/52 • Number of events 1 • 2 Years
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|
Cardiac disorders
Atrial fibrillation
|
5.8%
3/52 • Number of events 3 • 2 Years
|
|
Cardiac disorders
Coronary artery disease
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1.9%
1/52 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Mitral valve insufficiency
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Multiple vessel coronary artery disease
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Myocardial infarction
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Non STEMI
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Cardiac disorders
Triple vessel disease
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Eye disorders
Cataract (right)
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Gastrointestinal disorders
Esophagitis ulcerative
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Infections and infestations
Aspiration pneumonia
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Infections and infestations
Erysipelas
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Infections and infestations
Perineal abscess
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Infections and infestations
Pyelonephritis
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Infections and infestations
Urosepsis
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Fracture of pelvis
|
1.9%
1/52 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Fractured ribs
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Lumbar vertebral fracture L3
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Peripheral arterial reocclusion
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Injury, poisoning and procedural complications
Post angioplasty restenosis
|
7.7%
4/52 • Number of events 4 • 2 Years
|
|
Injury, poisoning and procedural complications
Second degree burns
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Shoulder fracture
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Injury, poisoning and procedural complications
Superficial femoral arterial restenosis
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Metabolism and nutrition disorders
Diabetes mellitus aggravated
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Musculoskeletal and connective tissue disorders
Limb hyperextension
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma recurrent
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Bleeding intracranial
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Cerebral infarction
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Nervous system disorders
Nerve root impingement
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Reproductive system and breast disorders
Vaginal prolapse
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Vascular disorders
Adventitial cystic disease
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Vascular disorders
Femoral artery dissection
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Vascular disorders
Femoral artery stenosis
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Vascular disorders
Femoropopliteal stenosis
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Vascular disorders
Hypertensive crisis
|
1.9%
1/52 • Number of events 2 • 2 Years
|
|
Vascular disorders
Iliac artery dissection
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Vascular disorders
Iliac artery stenosis
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Vascular disorders
Peripheral artery dissection
|
1.9%
1/52 • Number of events 1 • 2 Years
|
|
Vascular disorders
Peripheral artery occlusion
|
3.8%
2/52 • Number of events 2 • 2 Years
|
|
Vascular disorders
Peripheral artery stenosis
|
3.8%
2/52 • Number of events 2 • 2 Years
|
Other adverse events
| Measure |
Drug Coated Balloon
n=52 participants at risk
Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
Drug Coated Balloon: Prospective, multi-center, single-arm study characterizing outcomes in subjects with Peripheral Artery Disease (PAD) lesions treated with percutaneous transluminal angioplasty (PTA) using the GORE® DCB Catheter.
|
|---|---|
|
Injury, poisoning and procedural complications
Post angioplasty restenosis
|
21.2%
11/52 • Number of events 11 • 2 Years
|
|
Injury, poisoning and procedural complications
Superficial femoral arterial restenosis
|
7.7%
4/52 • Number of events 4 • 2 Years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place