Trial Outcomes & Findings for Study of BioNIR Drug Eluting Stent System in Coronary Stenosis (NCT NCT01995487)

NCT ID: NCT01995487

Last Updated: 2023-10-16

Results Overview

The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1919 participants
• Primary outcome timeframe: 12 months
• Results posted on: 2023-10-16

Participant Flow

Participant milestones

Measure	BioNIR The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent). BioNIR: drug-eluting stent	Resolute The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: 1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent 2. Delivery system (Rapid Exchange \[RX\] Coronary System) 3. Polymer system 4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area. Resolute: drug-eluting stent
Overall Study STARTED	958	961
Overall Study COMPLETED	884	878
Overall Study NOT COMPLETED	74	83

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Study of BioNIR Drug Eluting Stent System in Coronary Stenosis

Baseline characteristics by cohort

Measure	BioNIR n=958 Participants The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent). BioNIR: drug-eluting stent	Resolute n=961 Participants The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: 1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent 2. Delivery system (Rapid Exchange \[RX\] Coronary System) 3. Polymer system 4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area. Resolute: drug-eluting stent	Total n=1919 Participants Total of all reporting groups
Race (NIH/OMB) Black or African American	24 Participants n=5 Participants	25 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) White	914 Participants n=5 Participants	922 Participants n=7 Participants	1836 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	509 Participants n=5 Participants	506 Participants n=7 Participants	1015 Participants n=5 Participants
Age, Categorical >=65 years	449 Participants n=5 Participants	455 Participants n=7 Participants	904 Participants n=5 Participants
Age, Continuous	63.7 years STANDARD_DEVIATION 10.2 • n=5 Participants	63.1 years STANDARD_DEVIATION 10.3 • n=7 Participants	63.4 years STANDARD_DEVIATION 10.3 • n=5 Participants
Sex: Female, Male Female	208 Participants n=5 Participants	174 Participants n=7 Participants	382 Participants n=5 Participants
Sex: Female, Male Male	750 Participants n=5 Participants	787 Participants n=7 Participants	1537 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Asian	17 Participants n=5 Participants	11 Participants n=7 Participants	28 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants	1 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

The primary endpoint of TLF at 12 months was defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR.

Outcome measures

Measure	BioNIR n=926 Participants Participants received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent).	Resolute n=930 Participants Participants received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: 1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent 2. Delivery system (Rapid Exchange \[RX\] Coronary System) 3. Polymer system 4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area.
Target Lesion Failure (TLF)	5.4 percentage of TLF Interval 4.0 to 7.1	5.4 percentage of TLF Interval 4.0 to 7.0

SECONDARY outcome

Timeframe: Determined at time of baseline procedure

Clinical: Acute secondary endpoint determined at time of baseline procedure

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical secondary endpoint to be evaluated at 30 days, 6 months, and 2, 3, 4 and 5 years, defined as the composite of cardiac death, target vessel-related MI, or ischemia-driven TLR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: MACE; the composite rate of cardiac death, any MI or ischemia-driven TLR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: TVF; the composite rate of death, target vessel related MI or ischemia-driven TVR

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: The number of patients who die from all causes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: The number of patients who die of cardiac-related causes

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: The number of patients who suffer a myocardial infarction.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: The number of patients who suffer a MI that is related to the target vessel of the procedure.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical:

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical:

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 30 days, 6 months, and 1, 2, 3, 4 and 5 years

Clinical: ARC definite and probable

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 months

Secondary Endpoint for angiographic in-stent and in-segment late loss

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 months

IVUS: In-stent percent neointimal hyperplasia

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 13 months

IVUS Sub-Study: Stent mal-apposition

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Determined at time of baseline procedure

Measures whether the lesion was successfully treated.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Determined at time of baseline procedure

Acute clinical endpoint: The success of the procedure as determined at time of baseline procedure

Outcome measures

Outcome data not reported

Adverse Events

BioNIR

Serious events: 247 serious events

Other events: 370 other events

Deaths: 5 deaths

Resolute

Serious events: 242 serious events

Other events: 364 other events

Deaths: 2 deaths

Serious adverse events

Measure	BioNIR n=945 participants at risk Subjects received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent). BioNIR: drug-eluting stent	Resolute n=954 participants at risk Subjects received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: 1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent 2. Delivery system (Rapid Exchange \[RX\] Coronary System) 3. Polymer system 4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area. Resolute: drug-eluting stent
Blood and lymphatic system disorders blood and lymphatic system disorders	0.53% 5/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Cardiac disorders cardiac disorders	16.8% 159/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	13.0% 124/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Ear and labyrinth disorders ear and labyrinth disorders	0.11% 1/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.31% 3/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Eye disorders eye disorderd	0.11% 1/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.00% 0/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Gastrointestinal disorders gastrointestineal disorders	2.8% 26/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.3% 22/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
General disorders general disorders and administration site condition	6.0% 57/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	7.4% 71/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Hepatobiliary disorders hepatobiliary disorders	0.42% 4/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.21% 2/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Immune system disorders immune system disorders	0.21% 2/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Infections and infestations infections and infestations	1.6% 15/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.0% 19/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Injury, poisoning and procedural complications injury, poisoning and procedural complications	1.2% 11/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.5% 14/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Metabolism and nutrition disorders metabolism and nutrition disorders	0.32% 3/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorders	0.53% 5/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.42% 4/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benign, malignant and unspecified	0.95% 9/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.0% 19/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Nervous system disorders nervous system disorders	2.8% 26/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.8% 27/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Psychiatric disorders psychiatric disorders	0.42% 4/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.00% 0/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Renal and urinary disorders renal and urinary disorders	1.2% 11/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.3% 12/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Reproductive system and breast disorders reproductive system and breast disorders	0.21% 2/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.85% 8/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.7% 16/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Surgical and medical procedures Surgical and medical procedures	0.32% 3/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.42% 4/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Vascular disorders Vascular disorders	0.85% 8/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.9% 18/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.

Other adverse events

Measure	BioNIR n=945 participants at risk Subjects received The BioNIR Ridaforolimus Eluting Coronary Stent System is a single use device/drug combination product comprising: * Stent - a mounted Cobalt Chromium (CoCr) alloy based stent * Delivery System - Rapid Exchange (RX) Coronary System * Polymer matrix coating - Poly n-butyl methacrylate (PBMA) and CarboSil® * Ridaforolimus drug - CAS Registry Number: 572924-54-0 The drug Ridaforolimus is utilized on the stent system at a dose of 1.1 μg/mm2 (with a drug load of 100 μg per 2.75/3.00 x 17 mm stent). BioNIR: drug-eluting stent	Resolute n=954 participants at risk Subjects received The Endeavor Resolute Zotarolimus-Eluting Stent System consists of four subsystems: 1. Endeavor Resolute Stent- a pre-mounted cobalt alloy based stent 2. Delivery system (Rapid Exchange \[RX\] Coronary System) 3. Polymer system 4. Zotarolimus - drug The Resolute has a nominal drug dose of 1.6µg Zotarolimus per mm2 of the stent surface area. Resolute: drug-eluting stent
Blood and lymphatic system disorders Blood and lymphatic system disorders	0.53% 5/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Cardiac disorders Cardiac Disorders	16.8% 159/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	13.0% 124/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Ear and labyrinth disorders ear and labyrinth disorders	0.11% 1/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.31% 3/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Eye disorders Eye disorders	0.11% 1/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.00% 0/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Gastrointestinal disorders Gastrointestinal disorders	2.8% 26/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.3% 22/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
General disorders General disorders and administration site conditions	6.0% 57/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	7.4% 71/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Hepatobiliary disorders hepatobiliary disorders	0.42% 4/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.21% 2/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Immune system disorders immune system disorders	0.21% 2/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Infections and infestations infections and infestations	1.6% 15/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.0% 19/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Injury, poisoning and procedural complications Injury, poisoning and procedural complications	1.2% 11/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.5% 14/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Metabolism and nutrition disorders metabolism and nutrition disorders	0.32% 3/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Musculoskeletal and connective tissue disorders musculoskeletal and connective tissue disorders	0.53% 5/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.42% 4/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Neoplasms benign, malignant and unspecified (incl cysts and polyps) neoplasms benign, malignant and unspecified	0.95% 9/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.0% 19/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Nervous system disorders nervous system disorders	2.8% 26/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	2.8% 27/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Psychiatric disorders psychiatric disorders	3.6% 34/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.00% 0/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Renal and urinary disorders renal and urinary disorders	1.2% 11/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.3% 12/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Reproductive system and breast disorders reproductive system and breast disorders	0.85% 8/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.7% 16/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	0.85% 8/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.7% 16/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	0.00% 0/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.10% 1/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Surgical and medical procedures Surgical and medical procedures	0.32% 3/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	0.42% 4/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.
Vascular disorders Vascular disorders	0.85% 8/945 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.	1.9% 18/954 • The Investigator monitored the occurrence of adverse events for each subject during the whole course of the trial - baseline and post procedure, 30 days, 6 months, 1 year, 2 years, 3 years, 4 years and 5 years visits.

Additional Information

Dina Kofler, VP Clinical Affairs

Medinol

Phone: +97237679032

Email: dinak@medinol.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place