Clinical trial NCT04080700: Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Official title: Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronary Artery Disease
Radial Artery
Puncture
Lead sponsor: Wonju Severance Christian Hospital
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 5000
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who need coronary angiography will be enrolled.

Brief summary: The left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. However, there is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. This prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

Detailed description: Based on the results that radial approach (RA) reduced mortality and bleeding complications compared with femoral approach (FA), RA has become the standard of care for coronary angiography (CAG) and percutaneous coronary intervention (PCI). RA provides better comfortability for the patients and immediate mobilization after CAG or PCI. Therefore, 2018 ESC/EACTS guidelines recommend RA as the standard approach, unless there are overriding procedural considerations.

Operators usually prefer right RA because most of the operators are right-handed and right hand of the patient is closer to the operator. In contrast, longer distance to the left radial artery cause neck or back sprain of the operators, especially when the height of the operator is short, or the patient is obese. Nevertheless, left RA might be easier to manipulate catheter because of less tortuosity compared to the right RA and similar approach curvature with FA. Left RA also gives a chance to the right-handed patients to use their right hand freely.

Recently, the left distal radial approach (DRA) has been introduced as a feasible and safe alternative route of the radial artery. The left hand in the prone position is placed either on the left groin or beside the left hip according to operator preference. The operator punctures the distal radial artery around the anatomical snuffbox. After the first report for the feasibility and safety of left DRA in 70 patients, Lee et al. demonstrated that the success rates of arterial puncture, CAG and PCI were 95.5% (191/200), 100% (187/187), and 98.9% (86/87), respectively. The complication rates were only 7.9% including 14 (7.4%) minor hematomas and one (0.5%) arterial dissection. No serious complications were occurred such as distal radial artery occlusion, perforation, pseudoaneurysm, or arteriovenous fistula. Several studies for DRA also showed similar favorable results regarding procedural success and bleeding complications.

Radial arterial occlusion after RA remains an unsolved problem. According to the Leipzig prospective vascular ultrasound registry, the occlusion rate of radial artery was 14.4% in case of 5Fr sheath and 33.1% in 6Fr sheath, respectively. In this point of view, DRA could be a promising solution to lower the incidence rate of arterial occlusion. Moreover, DRA can have a potential benefit in patients requiring arteriovenous fistula and in patients who need the radial artery as a conduit for coronary artery bypass graft because of the absence of radial injury.

There is still lack of evidence for DRA regarding the feasibility, safety, effective time for hemostasis and hemostasis method. Unknown complications related to DRA also should be addressed. Therefore, this prospective multicenter registry aimed to investigate the safety and efficacy of DRA for CAG and PCI.

Eligibility criteria: Inclusion Criteria:

* Patients aged ≥ 20 years who planned coronary angiography
* Patients with palpable distal radial artery
* Patients who give informed consent

Exclusion Criteria:

* Patients with small or non-palpable distal radial artery
* Positive result in modified Allen test (suspicious of single blood supply)
* Pregnant women, possible candidate for pregnancy, or breastfeeding women
* Patients who are deemed unsuitable by the investigator

Primary outcomes:
measure: Success rate of coronary angiography
timeFrame: Through procedure completion, up to 6 hours
measure: Success rate of percutaneous coronary intervention
timeFrame: Through procedure completion, up to 6 hours
Secondary outcomes:
measure: Success rate of distal radial artery puncture
timeFrame: Through procedure completion, up to 6 hours
measure: Puncture time
timeFrame: Through procedure completion, up to 6 hours
measure: Hemostasis time
timeFrame: Through procedure completion, up to 24 hours
measure: Puncture-related complications
timeFrame: Up to 1 month
measure: Total procedure time
timeFrame: Through procedure completion, up to 6 hours
measure: Total fluoroscopic time
timeFrame: Through procedure completion, up to 6 hours
measure: Total fluoroscopic dose
timeFrame: Through procedure completion, up to 6 hours
Other outcomes:
Locations:
city: Yongin-si
country: Korea, Republic of
facility: Yongin Severance Hospital
state: Kyeonggi-do
city: Busan
country: Korea, Republic of
facility: Inje University Busan Paik Hospital
city: Busan
country: Korea, Republic of
facility: Inje University Haeundae Paik Hospital
city: Busan
country: Korea, Republic of
facility: Kosin Univeristy Gospel Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Cheongju
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Chuncheon
country: Korea, Republic of
facility: Kangwon National University Hospital
city: Daegu
country: Korea, Republic of
facility: Daegu Catholic University Medical Center
city: Gangneung
country: Korea, Republic of
facility: GangNeung Asan Hospital
city: Goyang
country: Korea, Republic of
facility: Inje University Ilsan Paik Hospital
city: Gyeongju
country: Korea, Republic of
facility: Dongguk University Gyeongju Hospital
city: Incheon
country: Korea, Republic of
facility: Uvis Hospital
city: Uijeongbu
country: Korea, Republic of
facility: The Catholic university of Korea Uijeongbu St. Mary's hospital
city: Wonju
country: Korea, Republic of
facility: Wonju Severance Christian Hospital
Study officials:
affiliation: Yonsei University Wonju College of Medicine, Wonju Severance Christian Hospital
name: Seung-Hwan Lee, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: