Trial Outcomes & Findings for Clinical Trial Investigating the Combination Therapy With Luminor DCB and iVolution Stent in TASC C and D Femoropopliteal Lesions (NCT NCT03347383)
NCT ID: NCT03347383
Last Updated: 2025-03-06
Results Overview
Freedom from clinically-driven TLR at 12 months: defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
100 participants
Primary outcome timeframe
12-month
Results posted on
2025-03-06
Participant Flow
A total of 100 study subjects were enrolled in a period of 14 months, between September 2017 and October 2018.
All enrolled patients were treated with the study device.
Participant milestones
| Measure |
Combination Therapy DCB + Stent
A total of 100 study subjects were enrolled in a period of 14 months, between September 2017 and October 2018.
Combination therapy DCB + stent: Patients were treated with the Luminor DCB and iVolution stent.
Patients were followed for 5 years.
|
|---|---|
|
Overall Study
STARTED
|
100
|
|
Overall Study
COMPLETED
|
49
|
|
Overall Study
NOT COMPLETED
|
51
|
Reasons for withdrawal
| Measure |
Combination Therapy DCB + Stent
A total of 100 study subjects were enrolled in a period of 14 months, between September 2017 and October 2018.
Combination therapy DCB + stent: Patients were treated with the Luminor DCB and iVolution stent.
Patients were followed for 5 years.
|
|---|---|
|
Overall Study
Death
|
39
|
|
Overall Study
Withdrawal by Subject
|
3
|
|
Overall Study
Lost to Follow-up
|
9
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Age, Continuous
|
73.5 years
STANDARD_DEVIATION 9.4 • n=100 Participants
|
|
Sex: Female, Male
Female
|
33 Participants
n=100 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=100 Participants
|
|
Region of Enrollment
Belgium
|
100 Participants
n=100 Participants
|
|
Nicotine abuse
Former
|
22 Participants
n=100 Participants
|
|
Nicotine abuse
current
|
48 Participants
n=100 Participants
|
|
Nicotine abuse
never
|
30 Participants
n=100 Participants
|
|
Hypertension
|
73 Participants
n=100 Participants
|
|
Diabetes
|
37 Participants
n=100 Participants
|
|
Hypercholesterolemia
|
63 Participants
n=100 Participants
|
|
Obesity
|
32 Participants
n=100 Participants
|
|
History of peripheral artery intervention
|
40 Participants
n=100 Participants
|
|
History of coronary intervention
|
23 Participants
n=100 Participants
|
|
History of cerebrovascular intervention
|
3 Participants
n=100 Participants
|
PRIMARY outcome
Timeframe: 12-monthPopulation: At twelve month, 5 patients had a TLR, 7 patients died, 1 withdrew his consent and 1 patient was lost-to-follow-up
Freedom from clinically-driven TLR at 12 months: defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Freedom From Clinically-driven TLR at 12 Months
|
5 participants
|
SECONDARY outcome
Timeframe: 6 and 12 months post-procedurePrimary patency rate at 6-,12-month follow-up; defined as absence of a hemodynamically significant stenosis on duplex ultrasound (systolic velocity ratio no greater than 2.5) at the target lesion and without TLR within the time of procedure and the given follow-ups
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Primary Patency Rate
Number of patient who lost their Primary patency at 6 months
|
7 participants
|
|
Primary Patency Rate
Number of patient who lost their Primary patency at 12 months
|
8 participants
|
SECONDARY outcome
Timeframe: Index procedureTechnical success: defined as the ability to cross and dilate the lesion and achieve residual angiographic stenosis no greater than 30%
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Technical Success
|
100 Participants
|
SECONDARY outcome
Timeframe: 6, 24, 36, 48 and 60 months post-procedureFreedom from clinically-driven Target Lesion Revascularisation (CD-TLR) at 6-month, 2-, 3-, 4- and 5-year follow-up; TLR defined as a repeated intervention to maintain or re-establish patency within the region of the treated arterial vessel plus 5mm proximal and distal to the treated lesion edge at the respective time points
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Freedom From Clinically-driven TLR
Number of patients with CD-TLR at 6 months
|
1 participants
|
|
Freedom From Clinically-driven TLR
Number of patients with CD-TLR at 2 years
|
10 participants
|
|
Freedom From Clinically-driven TLR
Number of patients with CD-TLR at 3 years
|
17 participants
|
|
Freedom From Clinically-driven TLR
Number of patients with CD-TLR at 4 years
|
20 participants
|
|
Freedom From Clinically-driven TLR
Number of patients with CD-TLR at 5 years
|
25 participants
|
SECONDARY outcome
Timeframe: 1, 6, 12, 24, 36, 48 and 60 months post-procedurePopulation: Not all patients had a 1 to 60-month follow-up (e.g. missed visits, patients died, lost-to follow-up, ....) . As a result, not all 100 rutherford measurements were available for each visit.
Clinical success at follow-up is defined as an improvement of Rutherford classification at 1-, 6-, 12-, 24-, 36-, 48- and 60-month follow-up of one class or more as compared to the pre-procedure Rutherford classification.
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 1-month follow-up.
|
84 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 6-month follow-up.
|
79 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 12-month follow-up.
|
74 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 24-month follow-up.
|
56 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 36-month follow-up.
|
47 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 48-month follow-up.
|
39 Participants
|
|
Clinical Success
Number of patients whose RCC was improved compared to baseline at 60-month follow-up.
|
25 Participants
|
SECONDARY outcome
Timeframe: up to 60 months post-procedureSerious adverse events as defined per ISO 14155:2011
Outcome measures
| Measure |
Combination Therapy DCB + Stent
n=100 Participants
Patients treated with the Luminor DCB and the iVolution stent
Combination therapy DCB + stent: Patients will be treated with the Luminor DCB and iVolution stent
|
|---|---|
|
Serious Adverse Events (SAEs)
|
226 serious adverse events
|
Adverse Events
Combination Therapy DCB + Stent
Serious events: 80 serious events
Other events: 44 other events
Deaths: 39 deaths
Serious adverse events
| Measure |
Combination Therapy DCB + Stent
n=100 participants at risk
At the time of this 60-month follow-up report, there were 295 adverse events. 226 events were serious adverse events (SAEs). Of the 295 events, 61 were indicated as mild, 125 as moderate and 109 as severe. Forty-seven were study lesion related, 39 events were device related and 25 events were procedure related. The device and procedure related events were classified as highly probable, probable or unlikely related. Thirty-nine subjects died in this 60-month follow-up period, from which none of the causes of death were procedure or device related. All device and procedure related events reported during this period are considered anticipated.
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Vascular disorders
CVA
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Vascular disorders
CVA resulted in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Blood and lymphatic system disorders
Other
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Blood and lymphatic system disorders
Post-transplant lymphoproliferative disorder resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Cardiac disorders
Atrial fibrillation
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Cardiac disorders
CABG
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Cardiac disorders
Cardiac arrest resulted in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Cardiac disorders
Heart failure
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Cardiac disorders
Heart failure resulted in death
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Cardiac disorders
Other
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Endocrine disorders
Difficult metabolic control of DM type 1
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Eye disorders
Cataract
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Gastrointestinal disorders
Cholecystitis
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Carcinoma resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Colon carcinoma
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Colon polyps
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Gastrointestinal disorders
Gastro-intestinal bleeding resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Obstruction
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Gastrointestinal disorders
Other
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
General disorders
Deterioration of general health resulted in death
|
10.0%
10/100 • Number of events 10 • 5 years post procedure
|
|
General disorders
Deterioration of general health
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
General disorders
Organ failure resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
General disorders
Other
|
7.0%
7/100 • Number of events 10 • 5 years post procedure
|
|
General disorders
Sepsis
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
General disorders
Sepsis resulted in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Gastrointestinal disorders
Pancreatitis
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Infections and infestations
COVID infection resulted in death
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Infections and infestations
Foot wound
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Fracture
|
5.0%
5/100 • Number of events 5 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Osteomyelitis
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Other
|
3.0%
3/100 • Number of events 5 • 5 years post procedure
|
|
Blood and lymphatic system disorders
Large intracranial bleeding resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Nervous system disorders
Dementia resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Nervous system disorders
Epileptic seizure resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Nervous system disorders
Other
|
2.0%
2/100 • Number of events 4 • 5 years post procedure
|
|
Nervous system disorders
Stroke resulted in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Nervous system disorders
Vertigo
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Renal and urinary disorders
AV fistula procedure
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Renal and urinary disorders
Renal insufficiency
|
3.0%
3/100 • Number of events 5 • 5 years post procedure
|
|
Renal and urinary disorders
Infection
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Renal and urinary disorders
Kidney insufficiency resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Chronic lung disease with emphysema resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Dysnea
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Long embolism resulting in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Lung cancer resulting in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia resulted in death
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure resulted in death
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Tumour
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Skin and subcutaneous tissue disorders
Foot wound
|
8.0%
8/100 • Number of events 14 • 5 years post procedure
|
|
Vascular disorders
Aneurysm
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Vascular disorders
Arterial stenosis/occlusion
|
39.0%
39/100 • Number of events 83 • 5 years post procedure
|
|
Vascular disorders
Other
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
Other adverse events
| Measure |
Combination Therapy DCB + Stent
n=100 participants at risk
At the time of this 60-month follow-up report, there were 295 adverse events. 226 events were serious adverse events (SAEs). Of the 295 events, 61 were indicated as mild, 125 as moderate and 109 as severe. Forty-seven were study lesion related, 39 events were device related and 25 events were procedure related. The device and procedure related events were classified as highly probable, probable or unlikely related. Thirty-nine subjects died in this 60-month follow-up period, from which none of the causes of death were procedure or device related. All device and procedure related events reported during this period are considered anticipated.
|
|---|---|
|
Skin and subcutaneous tissue disorders
burn wound
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Blood and lymphatic system disorders
Hematuria
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Blood and lymphatic system disorders
Other
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Cardiac disorders
Arrhythmia
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Cardiac disorders
Cardiac decompensation
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Endocrine disorders
Hyperthyroidism
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Eye disorders
Diabetic retinopathy
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Inflammation
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Infection
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Gastrointestinal disorders
Melena
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
General disorders
Dizzines
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
General disorders
Gout
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
General disorders
Other
|
1.0%
1/100 • Number of events 2 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Arthrosis
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Inflammation
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Other
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Musculoskeletal and connective tissue disorders
Pain
|
7.0%
7/100 • Number of events 7 • 5 years post procedure
|
|
Nervous system disorders
Carpal tunnel syndrome
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Nervous system disorders
Cognitive disorder
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Renal and urinary disorders
Urinary retention
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Respiratory, thoracic and mediastinal disorders
Embolism
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
|
Skin and subcutaneous tissue disorders
Inflammation
|
2.0%
2/100 • Number of events 2 • 5 years post procedure
|
|
Skin and subcutaneous tissue disorders
Wound
|
3.0%
3/100 • Number of events 3 • 5 years post procedure
|
|
Skin and subcutaneous tissue disorders
Edema
|
4.0%
4/100 • Number of events 4 • 5 years post procedure
|
|
Vascular disorders
Arterial stenosis/occlusion
|
20.0%
20/100 • Number of events 21 • 5 years post procedure
|
|
Vascular disorders
Pseudoaneurysm
|
1.0%
1/100 • Number of events 1 • 5 years post procedure
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place