Trial Outcomes & Findings for CVT-ISR First in Human Trial for Coronary In-Stent Restenosis (NCT NCT05731700)
NCT ID: NCT05731700
Last Updated: 2025-09-19
Results Overview
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
COMPLETED
NA
51 participants
6 months post-index procedure
2025-09-19
Participant Flow
A total 51 subjects were enrolled in the CVT-ISR study at nine (9) investigational sites in Europe between October 20, 2021, and April 21, 2022.
Participant milestones
| Measure |
Drug Eluting Balloon
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Overall Study
STARTED
|
51
|
|
Overall Study
COMPLETED
|
50
|
|
Overall Study
NOT COMPLETED
|
1
|
Reasons for withdrawal
| Measure |
Drug Eluting Balloon
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Overall Study
Death
|
1
|
Baseline Characteristics
CVT-ISR First in Human Trial for Coronary In-Stent Restenosis
Baseline characteristics by cohort
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Age, Continuous
|
69.2 years
STANDARD_DEVIATION 11.2 • n=5 Participants
|
|
Sex/Gender, Customized
Male
|
38 Participants
n=5 Participants
|
|
Sex/Gender, Customized
Female
|
13 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
27 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
18 Participants
n=5 Participants
|
|
Prior Percutaneous coronary revascularization (Prior PCI)
|
51 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months post-index procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Target Lesion Failure
|
4 Participants
|
|
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Cardiovascular Death
|
1 Participants
|
|
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Target Vessel MI
|
0 Participants
|
|
The Primary Safety Endpoint for the CVT-ISR Study: Freedom From Target Lesion Failure (TLF) Rate
Clinically-Driven Target Lesion Revascularization
|
3 Participants
|
PRIMARY outcome
Timeframe: 180 days post-procedurePopulation: The number of participants analyzed includes subjects who were available at that time of analysis
In-Stent Late Lumen Loss (LLL) measures the reduction in the luminal diameter of a stented artery over a specified period after stent implantation, typically assessed using angiographic imaging. The unit of measurement for this outcome is expressed in millimeters (mm) or percentage (%), depending on the reporting method. The LLL is calculated by comparing the luminal diameter at a follow-up time point to the post-procedure luminal diameter.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
The Primary Effectiveness Endpoint for the CVT-ISR Study: In-stent Late Lumen Loss (LLL)
|
0.40 millimeters (mm)
Standard Deviation 0.48
|
SECONDARY outcome
Timeframe: 30 days post-procedure and 12 monthsPopulation: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TLR cumulative at each timepoint.
TLF is defined as composite rate of cardiovascular death, target vessel myocardial infarction and clinically-driven target lesion revascularization (TLR).
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Composite Rate of Target Lesion Failure (TLF)
30 days post-procedure
|
1 Participants
|
|
Composite Rate of Target Lesion Failure (TLF)
12 months
|
5 Participants
|
SECONDARY outcome
Timeframe: 30 days post-procedure, 180 days and 12 monthsPopulation: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TVR cumulative at each timepoint.
Target vessel failure (TVF) is defined as composite rate of cardiovascular death, target vessel myocardial infarction, and clinically-driven target vessel revascularization (TVR).
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Composite Rate of Target Vessel Failure (TVF)
30 days post-procedure
|
1 Participants
|
|
Composite Rate of Target Vessel Failure (TVF)
180 days
|
7 Participants
|
|
Composite Rate of Target Vessel Failure (TVF)
12 months
|
9 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TLR cumulative at each timepoint.
TLR is defined as any repeat PCI of the target lesion or bypass surgery of the target vessel performed for restenosis or other complication of the target lesion.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Clinically Driven Target Lesion Revascularization (TLR)
|
4 Participants
|
SECONDARY outcome
Timeframe: 180 days and 12 monthsPopulation: Analysis population includes all intent to treat (ITT) patients with cardiovascular death, target vessel MI and clinically-driven TVR cumulative at each timepoint.
TVR is defined as any repeat percutaneous intervention or surgical bypass of any segment of the target vessel including the target lesion.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Clinically-driven Target Vessel Revascularization (TVR)
180 days
|
5 Participants
|
|
Clinically-driven Target Vessel Revascularization (TVR)
12 months
|
7 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: Analysis population includes all intent to treat (ITT) patients with access site complications of Hematoma, AV Fistula or Pseudoaneurysm.
The rate of vascular access site complications is defined as the combined rate of hematoma, AV fistula or a pseudoaneurysm that required intervention, such as surgical repair, transfusion or a prolonged hospital stay or requiring a new hospital admittance.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Rate of Vascular Access Site Complications
Hematoma
|
0 Participants
|
|
Rate of Vascular Access Site Complications
AV Fistula
|
0 Participants
|
|
Rate of Vascular Access Site Complications
Pseudoaneurysm
|
0 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Lesion success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using any device after wire passage through the lesion.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Lesion Success:
|
50 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Technical success, defined as achievement of a final in-lesion residual diameter stenosis of \<30% (by QCA), using the CVT Everolimus coated PTCA Catheter without a device malfunction after wire passage through the lesion.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Technical Success
|
47 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Clinical success (per subject) defined as technical success without the occurrence of major adverse cardiac events during the procedure.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Clinical Success (Per Subject)
|
48 Participants
|
SECONDARY outcome
Timeframe: 12 monthsPopulation: The number of participants analyzed includes subjects who were available at that time of analysis
Procedural success (per subject) defined as lesion success without the occurrence of major adverse cardiac events during the procedure.
Outcome measures
| Measure |
Drug Eluting Balloon
n=51 Participants
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Procedural Success
|
50 Participants
|
Adverse Events
Drug Eluting Balloon
Serious adverse events
| Measure |
Drug Eluting Balloon
n=51 participants at risk
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
Cardiac disorders
Restenosis, non-target lesion
|
7.8%
4/51 • 12 Months
|
|
Cardiac disorders
Angina, Unstable
|
3.9%
2/51 • 12 Months
|
|
Cardiac disorders
Stroke Suspicion
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
Stable angina
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
CABG, non-treated lesion
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
CABG, target vessel
|
2.0%
1/51 • 12 Months
|
|
Injury, poisoning and procedural complications
Coronary Artery Restenosis
|
9.8%
5/51 • 12 Months
|
|
Injury, poisoning and procedural complications
Procedural Dissection
|
2.0%
1/51 • 12 Months
|
|
General disorders
Chest Pain
|
2.0%
1/51 • 12 Months
|
|
General disorders
Sternal wound
|
2.0%
1/51 • 12 Months
|
|
General disorders
Thoracic Pain
|
2.0%
1/51 • 12 Months
|
|
General disorders
Sudden Death, unknown cause
|
2.0%
1/51 • 12 Months
|
|
General disorders
Death, failure to thrive
|
2.0%
1/51 • 12 Months
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • 12 Months
|
|
Gastrointestinal disorders
GI Bleeding
|
2.0%
1/51 • 12 Months
|
|
Vascular disorders
Abdominal Aorta Aneurysm
|
2.0%
1/51 • 12 Months
|
|
General disorders
Lower Limb Ischemia
|
2.0%
1/51 • 12 Months
|
Other adverse events
| Measure |
Drug Eluting Balloon
n=51 participants at risk
Treatment of a single in-stent restenosis coronary artery lesion with drug eluting balloon
Drug Eluting Balloon: PCI of in-stent restenosis
|
|---|---|
|
General disorders
Target lesion restenosis
|
2.0%
1/51 • 12 Months
|
|
Injury, poisoning and procedural complications
Coronary artery restenosis
|
5.9%
3/51 • 12 Months
|
|
Injury, poisoning and procedural complications
Procedural dissection
|
2.0%
1/51 • 12 Months
|
|
Renal and urinary disorders
Urinary tract infection
|
2.0%
1/51 • 12 Months
|
|
Renal and urinary disorders
Erectile dysfunction
|
2.0%
1/51 • 12 Months
|
|
Renal and urinary disorders
Hematuria
|
2.0%
1/51 • 12 Months
|
|
Gastrointestinal disorders
Gastritis
|
2.0%
1/51 • 12 Months
|
|
Gastrointestinal disorders
GI bleeding
|
2.0%
1/51 • 12 Months
|
|
Infections and infestations
Skin/Rash infection
|
3.9%
2/51 • 12 Months
|
|
Infections and infestations
Covid 19
|
3.9%
2/51 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/51 • 12 Months
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract infection
|
2.0%
1/51 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Cutaneous hemorrhage
|
2.0%
1/51 • 12 Months
|
|
Skin and subcutaneous tissue disorders
Erysipelas
|
2.0%
1/51 • 12 Months
|
|
Metabolism and nutrition disorders
Diabetes
|
2.0%
1/51 • 12 Months
|
|
Nervous system disorders
Faintness
|
2.0%
1/51 • 12 Months
|
|
General disorders
Gingivorrhagia
|
2.0%
1/51 • 12 Months
|
|
Vascular disorders
Abdominal aorta aneurysm
|
2.0%
1/51 • 12 Months
|
|
General disorders
Thoracic pain
|
7.8%
4/51 • 12 Months
|
|
General disorders
Chest pain
|
5.9%
3/51 • 12 Months
|
|
General disorders
Hypertension
|
2.0%
1/51 • 12 Months
|
|
General disorders
Non-cardiovascular death
|
2.0%
1/51 • 12 Months
|
|
General disorders
Positive stress test
|
2.0%
1/51 • 12 Months
|
|
General disorders
Post-surgical injury
|
2.0%
1/51 • 12 Months
|
|
General disorders
Sternal wound
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
Angina, stable
|
5.9%
3/51 • 12 Months
|
|
Cardiac disorders
Restenosis, non-treated lesion
|
5.9%
3/51 • 12 Months
|
|
Cardiac disorders
Bradycardia
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
Stroke suspicion
|
2.0%
1/51 • 12 Months
|
|
Cardiac disorders
Tachycardia
|
2.0%
1/51 • 12 Months
|
|
General disorders
Lower limb ischemia
|
3.9%
2/51 • 12 Months
|
|
General disorders
Temporary hand/leg paralysis
|
2.0%
1/51 • 12 Months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60