Trial Outcomes & Findings for Prevention of Radial Artery Occlusion After Transradial Access Using Nitroglycerin (NCT NCT03158532)

NCT ID: NCT03158532

Last Updated: 2024-12-09

Results Overview

Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

2040 participants

Primary outcome timeframe

2 to 24 hours after procedure

Results posted on

2024-12-09

Participant Flow

Participant milestones

Participant milestones
Measure
Placebo I/Placebo II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Overall Study
STARTED
510
510
510
510
Overall Study
COMPLETED
510
510
510
510
Overall Study
NOT COMPLETED
0
0
0
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Total
n=2040 Participants
Total of all reporting groups
Age, Continuous
61.52 years
STANDARD_DEVIATION 10.35 • n=510 Participants
62.06 years
STANDARD_DEVIATION 10.29 • n=510 Participants
61.52 years
STANDARD_DEVIATION 10.35 • n=510 Participants
62.06 years
STANDARD_DEVIATION 10.29 • n=510 Participants
61.79 years
STANDARD_DEVIATION 10.32 • n=2040 Participants
Sex: Female, Male
Female
188 Participants
n=510 Participants
199 Participants
n=510 Participants
199 Participants
n=510 Participants
188 Participants
n=510 Participants
774 Participants
n=2040 Participants
Sex: Female, Male
Male
322 Participants
n=510 Participants
311 Participants
n=510 Participants
311 Participants
n=510 Participants
322 Participants
n=510 Participants
1266 Participants
n=2040 Participants
Race and Ethnicity Not Collected
0 Participants
Race and Ethnicity were not collected from any participant.

PRIMARY outcome

Timeframe: 2 to 24 hours after procedure

Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Radial Artery Occlusion
13 Participants
13 Participants
10 Participants
13 Participants

SECONDARY outcome

Timeframe: 30 days after procedure

Incidence of radial artery occlusion as confirmed by absence of antegrade flow in vascular doppler ultrasound

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Late Radial Artery Occlusion
9 Participants
9 Participants
7 Participants
9 Participants

SECONDARY outcome

Timeframe: up to 24 hours after procedure

Pain felt by the patient in the forearm, assessed using numeric pain rating scale ranging from 0 to 10, 0 best (no pain) 10 worst (unbearable pain)

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Pain Assessment
2.7 score on a scale
Standard Deviation .42
2.4 score on a scale
Standard Deviation .37
2.7 score on a scale
Standard Deviation .42
2.4 score on a scale
Standard Deviation .37

SECONDARY outcome

Timeframe: During the realization of the procedure

Catheter friction, as experienced by the operator (subjective measure), during the realization of the procedure

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Spasm (Operator Evaluation)
12 Participants
10 Participants
10 Participants
12 Participants

SECONDARY outcome

Timeframe: Duration of the procedure

Total duration of the procedure in seconds, from puncture to haemostatic dressing.

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Procedure Duration
1,193.22 seconds
Standard Deviation 1,105.82
1,216.29 seconds
Standard Deviation 1,179.52
1,229.83 seconds
Standard Deviation 1,208.30
1,179.67 seconds
Standard Deviation 1,073.80

SECONDARY outcome

Timeframe: During the procedure

Total radiation used in the procedure

Outcome measures

Outcome measures
Measure
Placebo I/Placebo II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 Participants
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 Participants
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Radiation Exposure
584.52 mGy
Standard Deviation 497.54
591.30 mGy
Standard Deviation 524.38
599.78 mGy
Standard Deviation 559.61
576.09 mGy
Standard Deviation 457.49

Adverse Events

Placebo I/Placebo II

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Nitroglycerin I/Placebo II

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Placebo I /Nitroglycerin II

Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths

Nitroglycerin I /Nitroglycerin II

Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
Placebo I/Placebo II
n=510 participants at risk
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I/Placebo II
n=510 participants at risk
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 0,9% Saline 10 mL was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Placebo II: Saline 0,9% intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Placebo I /Nitroglycerin II
n=510 participants at risk
0,9% Saline 10 mL was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Placebo I: Saline 0,9% intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Nitroglycerin I /Nitroglycerin II
n=510 participants at risk
500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the start of a transradial procedure (right after sheath placement) and 500 microgram of Nitroglycerin (in 10 mL saline) was given intra-arterially through the sheath at the end of procedure (just before sheath removal). Nitroglycerin I: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, right after sheath placement and before catheterization. Nitroglycerin II: 500 microgram of Nitroglycerin intra-arterially administered through the radial sheath, just before sheath removal and before hemostasis.
Cardiac disorders
Hypotension
1.2%
6/510 • Number of events 6 • 30 days
Hand isquemia
2.4%
12/510 • Number of events 12 • 30 days
Hand isquemia
1.2%
6/510 • Number of events 6 • 30 days
Hand isquemia
2.5%
13/510 • Number of events 13 • 30 days
Hand isquemia

Additional Information

Roberto Léo da Silva

ISCS

Phone: 55 48 999099790

Results disclosure agreements

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