Trial Outcomes & Findings for PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis (NCT NCT00916279)
NCT ID: NCT00916279
Last Updated: 2017-02-27
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
41 participants
Primary outcome timeframe
6 months
Results posted on
2017-02-27
Participant Flow
Enrollment from June 3, 2009 through December 8, 2009 at 7 centers in Germany, Netherlands, and Belgium.
Participant milestones
| Measure |
Lutonix DCB Catheter
Lutonix Paclitaxel-Coated Balloon: PTCA
|
|---|---|
|
Overall Study
STARTED
|
41
|
|
Overall Study
30 Days
|
41
|
|
Overall Study
6 Months
|
41
|
|
Overall Study
24 Months
|
37
|
|
Overall Study
COMPLETED
|
37
|
|
Overall Study
NOT COMPLETED
|
4
|
Reasons for withdrawal
| Measure |
Lutonix DCB Catheter
Lutonix Paclitaxel-Coated Balloon: PTCA
|
|---|---|
|
Overall Study
Death
|
2
|
|
Overall Study
Lost to Follow-up
|
2
|
Baseline Characteristics
PERVIDEO I Registry, The Lutonix Paclitaxel-Coated Balloon Catheter for the Treatment of Coronary In-Stent Restenosis
Baseline characteristics by cohort
| Measure |
Lutonix Catheter
n=41 Participants
Lutonix Paclitaxel-Coated Balloon: PTCA
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
14 Participants
n=93 Participants
|
|
Age, Categorical
>=65 years
|
27 Participants
n=93 Participants
|
|
Age, Continuous
|
64.4 Years
STANDARD_DEVIATION 11.0 • n=93 Participants
|
|
Gender
Female
|
10 Participants
n=93 Participants
|
|
Gender
Male
|
31 Participants
n=93 Participants
|
|
Region of Enrollment
Belgium
|
1 participants
n=93 Participants
|
|
Region of Enrollment
Netherlands
|
4 participants
n=93 Participants
|
|
Region of Enrollment
Germany
|
36 participants
n=93 Participants
|
|
Target Lesion Location
CFX
|
17 participants
n=93 Participants
|
|
Target Lesion Location
LAD
|
13 participants
n=93 Participants
|
|
Target Lesion Location
RCA
|
11 participants
n=93 Participants
|
PRIMARY outcome
Timeframe: 6 monthsPopulation: ITT
Outcome measures
| Measure |
Lutonix DCB Catheter
n=41 Participants
Lutonix paclitaxel-coated PTCA balloon catheter
|
|---|---|
|
Percent Diameter Stenosis (%DS) in the Analysis Segment
|
36.0 Percentage stenosis of vessel diameter
Standard Deviation 17.6
|
PRIMARY outcome
Timeframe: 6 MonthsPopulation: ITT
Paired change in percent diameter stenosis (%DS) in the analysis segment from post-procedure through 6 months. I.e., %DS at follow-up less %DS post procedure per patient.
Outcome measures
| Measure |
Lutonix DCB Catheter
n=41 Participants
Lutonix paclitaxel-coated PTCA balloon catheter
|
|---|---|
|
Change in Diameter Stenosis (%DS) From Post-procedure Through 6 Months
|
8.5 percent diameter stenosis
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 6 monthsPopulation: ITT
Change in (loss of) lumen diameter from baseline through 6 months in the analysis segment (including the treated segment and 5mm proximal and distal).
Outcome measures
| Measure |
Lutonix DCB Catheter
n=41 Participants
Lutonix paclitaxel-coated PTCA balloon catheter
|
|---|---|
|
Late Lumen Loss
|
0.17 (mm)
Standard Deviation 0.39
|
SECONDARY outcome
Timeframe: 30 DaysPopulation: ITT
Major adverse coronary events (MACE), including the composite of cardiac death, myocardial infarction (MI), and target vessel revascularization (TVR).
Outcome measures
| Measure |
Lutonix DCB Catheter
n=41 Participants
Lutonix paclitaxel-coated PTCA balloon catheter
|
|---|---|
|
MACE Rate
|
0 Percentage of patients
|
SECONDARY outcome
Timeframe: 6 MonthsPopulation: ITT
Subjects with percent diameter stenosis \>50% in the analysis segment.
Outcome measures
| Measure |
Lutonix DCB Catheter
n=41 Participants
Lutonix paclitaxel-coated PTCA balloon catheter
|
|---|---|
|
Binary Restenosis
|
5 participants
|
Adverse Events
Lutonix Catheter
Serious events: 22 serious events
Other events: 15 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Lutonix Catheter
n=41 participants at risk
Lutonix Paclitaxel-Coated Balloon: PTCA
|
|---|---|
|
Injury, poisoning and procedural complications
Death of unknown cause
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Abdominal aortic aneurysm
|
2.4%
1/41 • Number of events 1
|
|
Renal and urinary disorders
Acute renal failure post-interventional
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Rotoblation of non-target vessel/fell into lung edema & ventricular fibrillation. Resulted in death
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Aneurysm spurium of RCA
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Aneurysma rupture by distal endoleak right iliacal
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Angina
|
14.6%
6/41 • Number of events 8
|
|
Infections and infestations
Bacteria MIC = staphylococcus auras
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Cardiac decomposition with pneumonia and sepsis and respiratory insufficiency due to pulmonary edema
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
CCSIII caused angio. Occlusion of prox. RCA NTVR done
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Effective reconstruction: RCA - 3 DES stents (atypical chest pain / discomfort, angiographic stenosi
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Hospitalization
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
Hypertensive Crisis
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Instent Restenosis
|
4.9%
2/41 • Number of events 2
|
|
Renal and urinary disorders
Kidney Stones
|
2.4%
1/41 • Number of events 1
|
|
General disorders
Nasal bleeding / epistaxis
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea and Thorax Pain
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Pericardial abscess
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Perimyocarditis with pericardial effusion
|
2.4%
1/41 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary edema
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Progression of coronary artery disease proximal to treated lesion (non-TLR-PCI)
|
2.4%
1/41 • Number of events 1
|
|
Psychiatric disorders
Recurrent Depressive disorder, pre-existing condition
|
2.4%
1/41 • Number of events 1
|
|
Injury, poisoning and procedural complications
Reintervention
|
2.4%
1/41 • Number of events 1
|
|
Cardiac disorders
Re-PCI
|
4.9%
2/41 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory insufficiency
|
2.4%
1/41 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.4%
1/41 • Number of events 1
|
|
Vascular disorders
Stenosis
|
9.8%
4/41 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic pain
|
2.4%
1/41 • Number of events 2
|
Other adverse events
| Measure |
Lutonix Catheter
n=41 participants at risk
Lutonix Paclitaxel-Coated Balloon: PTCA
|
|---|---|
|
Cardiac disorders
Angina
|
14.6%
6/41 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Chest Pain
|
9.8%
4/41 • Number of events 5
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.3%
3/41 • Number of events 3
|
|
Renal and urinary disorders
Hypertension
|
17.1%
7/41 • Number of events 7
|
|
Cardiac disorders
Palpitations
|
4.9%
2/41 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Thoracic Pain
|
9.8%
4/41 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER