Trial Outcomes & Findings for Belgian-Italian Trial to Evaluate the Efficacy and Safety of Below The Knee (BTK) Treatment With the Luminor 14 Paclitaxel Coated Percutaneous Transluminal Angioplasty Balloon Catheter of iVascular (NCT NCT03845543)
NCT ID: NCT03845543
Last Updated: 2024-11-08
Results Overview
Freedom from major adverse limb events (MALE) defined as absence of 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).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
150 participants
Primary outcome timeframe
6 months post-procedure
Results posted on
2024-11-08
Participant Flow
Participant milestones
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Overall Study
STARTED
|
150
|
|
Overall Study
COMPLETED
|
94
|
|
Overall Study
NOT COMPLETED
|
56
|
Reasons for withdrawal
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Overall Study
Death
|
25
|
|
Overall Study
Withdrawal by Subject
|
2
|
|
Overall Study
Lost to Follow-up
|
12
|
|
Overall Study
Adverse Event
|
17
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Age, Continuous
|
78 years
STANDARD_DEVIATION 9.5 • n=150 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=150 Participants
|
|
Sex: Female, Male
Male
|
103 Participants
n=150 Participants
|
|
Region of Enrollment
Belgium
|
131 participants
n=150 Participants
|
|
Region of Enrollment
Italy
|
9 participants
n=150 Participants
|
|
Region of Enrollment
Spain
|
10 participants
n=150 Participants
|
|
Nicotine abuse
|
53 Participants
n=150 Participants
|
|
Hypertension
|
120 Participants
n=150 Participants
|
|
Hypercholesterolemia
|
99 Participants
n=150 Participants
|
|
Previous arterial intervention
|
73 Participants
n=150 Participants
|
|
Previous coronary intervention
|
51 Participants
n=150 Participants
|
|
Previous cerebrovascular interventions
|
6 Participants
n=150 Participants
|
|
Diabetes
|
107 Participants
n=150 Participants
|
|
Obesity
|
41 Participants
n=150 Participants
|
|
Renal insufficiency
|
52 Participants
n=150 Participants
|
PRIMARY outcome
Timeframe: 6 months post-procedureFreedom from major adverse limb events (MALE) defined as absence of 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).
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Primary Efficacy Endpoint: Freedom From MALE
|
144 Participants
|
PRIMARY outcome
Timeframe: 30 days post-procedureFreedom from major adverse limb events defined as absence of 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).
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Primary Safety Endpoint: Freedom From MALE
|
148 Participants
|
PRIMARY outcome
Timeframe: 30 days post-procedureNo peri-operative death (POD) related to device, procedure or any other cause.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Primary Safety Endpoint: Freedom From POD
|
146 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post-procedureTarget vessel functional flow assessment defined as the presence of blood flow using duplex ultrasound. Evidence of no blood flow within the treated segment indicates loss of patency.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Target Vessel Functional Flow Assessment
6 months
|
133 Participants
|
|
Target Vessel Functional Flow Assessment
12 months
|
129 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post-procedureFreedom from clinical driven target lesion revascularization defined as absence of any reintervention due to clinical deterioration, defined as a worsening of the patient's quality of life, reflected by the health-questionnaire (EQ-5D), worsening of the Rutherford category with minimal 1 class or worsening of wound status.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Freedom From Clinically Driven Target Vessel Revascularisation
6 months
|
138 Participants
|
|
Freedom From Clinically Driven Target Vessel Revascularisation
12 months
|
133 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post-procedureAmputation free survival defined as alive with freedom from any above the ankle target limb amputation
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Amputation Free Survival
6 months
|
130 Participants
|
|
Amputation Free Survival
12 months
|
119 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post-procedureLimb salvage is defined as freedom from any above the ankle target limb amputation
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Limb Salvage
6 months
|
144 Participants
|
|
Limb Salvage
12 months
|
143 Participants
|
SECONDARY outcome
Timeframe: During index procedureProcedural success is defined as restoration of at least 1 below the knee artery with \<30% residual stenosis in the final angiogram and outflow into the foot.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Procedural Success
|
142 Participants
|
SECONDARY outcome
Timeframe: 1, 6 and 12 months post-procedureAt 1, 6 and 12 months visits, the healing status of each wound will be scored based on 3 parameters: Wound's diameter: 0 points for wounds with diameter \>9cm², 1 point for wounds with diameter 1-9cm², 2 points for wounds with diameter \<1cm² Wound's depth: 0 points for depth to the bone/joint wounds, 1 point depth to muscle/tendon wounds, 2 points depth to the skin or subcutaneous wounds % granulation tissue: 0 points for a wound with \<50% red granulation tissue, 1 point for a wound with 50-75% red granulation tissue, 2 points for a wound with \>75% red granulation tissue A total wound healing score is calculated by combining the 3 parameter points. E.g.:wound with diameter 1-9cm², depth to the bone, and \<50% red granulation tissue has a score of 1+0+0=1. A wound with a score 6/6 is the best possible score for a non-healed wound while a 0/6 is the worst score a wound can have. After all total wound healing scores are calculated, a mean for each follow-up visit is calculated.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Mean Wound Healing Status
1 month
|
4.4 score on a scale
Standard Deviation 1.4
|
|
Mean Wound Healing Status
6 months
|
4.4 score on a scale
Standard Deviation 1.4
|
|
Mean Wound Healing Status
12 months
|
4 score on a scale
Standard Deviation 1.3
|
SECONDARY outcome
Timeframe: 1, 6 and 12 months post-procedureWound healing time is defined as the number of days needed for the wound to heal completely after the index procedure.
Outcome measures
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 Participants
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Wound Healing Time
|
144 days
Standard Deviation 103
|
Adverse Events
Luminor-14 Paclitaxel Eluting Balloon
Serious events: 88 serious events
Other events: 45 other events
Deaths: 25 deaths
Serious adverse events
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 participants at risk
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.7%
4/150 • Number of events 7 • 12 months post-procedure
|
|
Blood and lymphatic system disorders
Cerebro vascular incident
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Blood and lymphatic system disorders
Septic shock resulted in death
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Blood and lymphatic system disorders
Shock
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Cardiac disorders
Arrhythmias
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Blood and lymphatic system disorders
CVA resulted in death
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Cardiac disorders
Heart disorder resulted in death
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Cardiac disorders
Heart failure
|
2.0%
3/150 • Number of events 3 • 12 months post-procedure
|
|
Eye disorders
Reticulopathy
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Gastrointestinal disorders
Cancer resulted in death
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Gastrointestinal disorders
Stomach ulcer
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Gastrointestinal disorders
Other
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
General disorders
Deterioration of general health
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
General disorders
Detoriation of general health resulted in death
|
7.3%
11/150 • Number of events 11 • 12 months post-procedure
|
|
General disorders
Other
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Infections and infestations
Lung infection
|
2.0%
3/150 • Number of events 3 • 12 months post-procedure
|
|
Infections and infestations
Covid infection resulted in death
|
2.7%
4/150 • Number of events 4 • 12 months post-procedure
|
|
Infections and infestations
Infected foot wound
|
6.0%
9/150 • Number of events 9 • 12 months post-procedure
|
|
Infections and infestations
Lung infection resulted in death
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Infections and infestations
Other
|
2.7%
4/150 • Number of events 4 • 12 months post-procedure
|
|
Injury, poisoning and procedural complications
Accidental fall
|
3.3%
5/150 • Number of events 5 • 12 months post-procedure
|
|
Injury, poisoning and procedural complications
Accidental fall resulted in death
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Musculoskeletal and connective tissue disorders
Foot wound
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
6.7%
10/150 • Number of events 10 • 12 months post-procedure
|
|
Musculoskeletal and connective tissue disorders
Other
|
2.7%
4/150 • Number of events 4 • 12 months post-procedure
|
|
Nervous system disorders
Other
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Renal and urinary disorders
Gallstone
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Renal and urinary disorders
Kidney failure
|
1.3%
2/150 • Number of events 4 • 12 months post-procedure
|
|
Renal and urinary disorders
Kindey faillure resulted in death
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Renal and urinary disorders
Other
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Reproductive system and breast disorders
Breast cancer
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Vascular disorders
Arterial stenosis/occlusion
|
22.7%
34/150 • Number of events 53 • 12 months post-procedure
|
|
Vascular disorders
Other
|
3.3%
5/150 • Number of events 5 • 12 months post-procedure
|
|
Skin and subcutaneous tissue disorders
Foot wound
|
16.0%
24/150 • Number of events 32 • 12 months post-procedure
|
Other adverse events
| Measure |
Luminor-14 Paclitaxel Eluting Balloon
n=150 participants at risk
Pre-dilatation of 180 seconds with a standard non-drug-coated semi-compliant balloon followed by a dilatation with a Luminor-14 paclitaxel eluting balloon (3µg/mm² balloon surface).
Luminor-14 Paclitaxel eluting balloon: Patients will be treated with the Luminor-14 paclitaxel eluting balloon
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Cardiac disorders
Other
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Gastrointestinal disorders
Dental removal
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
General disorders
Deterioration of general health
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
General disorders
Other
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Immune system disorders
Skin irritation
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Infections and infestations
Foot wound
|
2.7%
4/150 • Number of events 4 • 12 months post-procedure
|
|
Infections and infestations
Other
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Infections and infestations
Accidental fall
|
2.0%
3/150 • Number of events 3 • 12 months post-procedure
|
|
Musculoskeletal and connective tissue disorders
Other
|
2.7%
4/150 • Number of events 5 • 12 months post-procedure
|
|
Renal and urinary disorders
Kidney faillure
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
|
Renal and urinary disorders
Other
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Skin and subcutaneous tissue disorders
Foot wound
|
11.3%
17/150 • Number of events 24 • 12 months post-procedure
|
|
Vascular disorders
Pseudoaneurysm
|
2.7%
4/150 • Number of events 4 • 12 months post-procedure
|
|
Vascular disorders
Arterial stenosis/occlusion
|
5.3%
8/150 • Number of events 8 • 12 months post-procedure
|
|
Vascular disorders
Dissection
|
1.3%
2/150 • Number of events 2 • 12 months post-procedure
|
|
Skin and subcutaneous tissue disorders
Other
|
0.67%
1/150 • Number of events 1 • 12 months post-procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Investigator agrees not to make announcements or oral presentations in any context without the Sponsor's prior written consent, except as required by law or by court administrative order. The relevant manuscripts shall be thus submitted to the Sponsor for approval to ensure that no confidential matters are made public. Once clinical research and/or results have been approved for publication by the Sponsor, they are no longer subjected to this provision in regards to any form of disclosure.
- Publication restrictions are in place
Restriction type: OTHER