Trial Outcomes & Findings for DIstal vs Proximal Radial Artery Access for Cath (NCT NCT04318990)
NCT ID: NCT04318990
Last Updated: 2024-05-03
Results Overview
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
300 participants
Primary outcome timeframe
1 year
Results posted on
2024-05-03
Participant Flow
Patients who were undergoing a cardiac catheterization at Baylor Scott and White- The Heart Hospital Plano were considered for enrollment in the trial. Enrollment started in March 2020 and completed in December 2021.
Subjects who met the screening inclusion criteria and have not met any of the trial exclusion criteria were included in the study. Screening assessments were conducted through review of medical records and by interview after informed consent was signed. In addition, a mandatory screening assessment for research purposes included assessing the patency of the pRA and dRA using palpation first, and if both are palpable then doppler ultrasound.
Participant milestones
| Measure |
Distal Radial Artery Access
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Overall Study
STARTED
|
150
|
150
|
|
Overall Study
COMPLETED
|
112
|
104
|
|
Overall Study
NOT COMPLETED
|
38
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
DIstal vs Proximal Radial Artery Access for Cath
Baseline characteristics by cohort
| Measure |
Distal Radial Artery Access
n=150 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=150 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Total
n=300 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
65.9 years
STANDARD_DEVIATION 8.7 • n=5 Participants
|
67.3 years
STANDARD_DEVIATION 10.5 • n=7 Participants
|
66.6 years
STANDARD_DEVIATION 9.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
31 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
147 Participants
n=5 Participants
|
143 Participants
n=7 Participants
|
290 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
8 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
128 Participants
n=5 Participants
|
132 Participants
n=7 Participants
|
260 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
BMI
|
29.9 kg/m2
n=5 Participants
|
30.1 kg/m2
n=7 Participants
|
30.0 kg/m2
n=5 Participants
|
|
Diabetes Mellitus
|
51 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
96 Participants
n=5 Participants
|
|
Hypercholesteremia
|
27 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
|
Hypertension
|
112 Participants
n=5 Participants
|
120 Participants
n=7 Participants
|
232 Participants
n=5 Participants
|
|
Prior Myocardial Infarction
|
23 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
39 Participants
n=5 Participants
|
|
Prior CABG
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Prior PCI
|
25 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
56 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients who completed 1 year of follow up
Hand function questionnaire, Range: 0 (no disability) to 100 (most severe disability)
Outcome measures
| Measure |
Distal Radial Artery Access
n=112 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=104 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Quick Disabilities of the Arm Shoulder and Hand (DASH) Questionnaire Score (0-100)
|
0 DASH Score change from baseline
Interval -6.6 to 2.3
|
0 DASH Score change from baseline
Interval -4.6 to 2.9
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Patients who completed 1 year of follow up
Hand function: Thumb and forefinger pinch strength (kg)
Outcome measures
| Measure |
Distal Radial Artery Access
n=112 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=104 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Thumb and Forefinger Pinch Strength Test
|
-0.1 pinch grip(kg) change from baseline
Interval -1.1 to 1.0
|
-0.3 pinch grip(kg) change from baseline
Interval -1.0 to 0.7
|
PRIMARY outcome
Timeframe: 1 monthPopulation: Patients who completed 1 year of follow up
Hand grip strength test (kg)
Outcome measures
| Measure |
Distal Radial Artery Access
n=112 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=104 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Hand Grip Strength Test
|
0.7 hand grip (kg) change from baseline
Interval -3.0 to 4.5
|
1.3 hand grip (kg) change from baseline
Interval -2.0 to 4.3
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients who completed 1 year of follow up
Patients who required re-intervention using the radial artery up to 1 year following the initial intervention
Outcome measures
| Measure |
Distal Radial Artery Access
n=112 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=104 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Re-intervention Using the Radial Artery
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 1 yearPopulation: Patients who completed 1 year of follow up
Occurrence of distal radial artery occlusion and proximal radial artery occlusion for patients who had distal or proximal radial artery access
Outcome measures
| Measure |
Distal Radial Artery Access
n=112 Participants
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=104 Participants
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Radial Artery Occlusion
Distal
|
0 Participants
|
2 Participants
|
|
Radial Artery Occlusion
Proximal
|
0 Participants
|
1 Participants
|
|
Radial Artery Occlusion
No Radial Artery Occlusion
|
112 Participants
|
101 Participants
|
Adverse Events
Distal Radial Artery Access
Serious events: 4 serious events
Other events: 0 other events
Deaths: 1 deaths
Proximal Radial Artery Access
Serious events: 1 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Distal Radial Artery Access
n=150 participants at risk
Wrist rests on a comfortable underground which brings the wrist in passive ulnar flexion. Patient is asked to bring the thumb under the other four fingers. After disinfection, patient is covered with a sterile drape. Brachial drape is applied to the hand exposing the anatomical snuff box and the proximal radial. Under ultrasound guidance, local anesthesia applied by SC injection of 5cc of lidocaine filling the radial fossa. Puncture performed at the point of maximal pulsation proximal in the anatomical snuffbox. If fails, a puncture more distal, can be attempted. After successful anterior wall puncture a radial sheath wire is advanced. Proper position verified by fluoroscopy or by ultrasound to ensure the wire didn't traverse the palmar arch, followed by introduction of a hydrophilic sheath. After administration of a spasmolytic cocktail containing 200-400 mcg of nitroglycerin and 5 mg of verapamil, the operator can take up a position at the level of the patient's knees.
Distal radial artery access: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
Proximal Radial Artery Access
n=150 participants at risk
Half of the patients enrolled in the study undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized proximal radial access for cardiac catheterization.
Proximal radial artery surgery: Patients undergoing coronary angiography or angioplasty at The Heart Hospital Baylor Plano will be randomized 1:1 to distal or proximal radial access for cardiac catheterization.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure with hypoxia
|
0.00%
0/150 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
0.67%
1/150 • Number of events 1 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
|
Infections and infestations
COVID-19
|
0.67%
1/150 • Number of events 1 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
0.00%
0/150 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
|
Musculoskeletal and connective tissue disorders
Orthopedic Injury
|
1.3%
2/150 • Number of events 2 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
0.00%
0/150 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
|
Renal and urinary disorders
Gross hematuria
|
0.67%
1/150 • Number of events 1 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
0.00%
0/150 • 1 year
The adverse events monitored until 1 year after the index procedure are complications to related to the procedure including bleeding, hematoma, and radial occlusion. Serious adverse events are defined as usual, but exclude hospitalizations for treatment, which was elective or preplanned, for a pre-existing condition unrelated to the study and did not worsen and for outpatient emergency treatment for an event not fulfilling any of the definitions of serious not resulting in hospital admission.
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place