Coronary Artery Disease Clinical Trial
— DRAvsFRAOfficial title:
Distal Radial Artery Access in Comparison to Forearm Radial Artery Access for Cardiac Catheterization, a Randomized Controlled Trial
Verified date | June 2023 |
Source | An-Najah National University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The Distal Radial Access (DRA) to the coronaries has emerged recently. It's done via the distal radial artery in the radial fossa, which is known as the snuff-box. The rationale of conducting this research is to assess this new access advantages and disadvantages, in comparison with the standard conventional forearm radial access and examine if it's worthy to be a future alternative method for coronary angiography. It aims to randomly compare between the new distal radial access via the snuffbox and the conventional forearm radial access for percutaneous coronary angiography and angioplasty procedures. The objectives of comparing both procedures are to analyze the frequency of complications in terms of occlusion, arterial spasm, hematoma, and to weigh accesses effectiveness in terms of time and attempts to puncture, crossover rate, procedure duration, hemostasis time, and convenience of the patients and operators. Candidates for coronary angiography are being randomized into the interventional group to undergo the angiography through the distal radial artery as the access site, or the control group accessing through the radial artery in the forearm. Procedural and post procedural outcomes and complications are being reported while patients are in hospital. All patients undergo doppler ultrasonography within 24 hours after the procedure.
Status | Completed |
Enrollment | 212 |
Est. completion date | December 21, 2020 |
Est. primary completion date | December 21, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patients who agree to participate in the study and sign the consent form. - Patients with an indication for coronary catheterization - Clinically stable patients - Patients with palpable pulses on both access sites of the radial artery. Exclusion Criteria: - Patients with STEMI - Patients with radial AV shunt for hemodialysis - Patients with previous CABG using radial artery - Patients with previous CABG using LIMA, RIMA or both. - Patients with Renaud phenomenon or lymphedema |
Country | Name | City | State |
---|---|---|---|
Palestinian Territory, occupied | An-Najah National University Hospital | Nablus |
Lead Sponsor | Collaborator |
---|---|
An-Najah National University |
Palestinian Territory, occupied,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radial artery occlusion | Doppler Ultrasonography of the radial artery for occlusions along its course, in both groups. | Within 24 hours after the procedure. | |
Secondary | Puncture Time | Which is time from first attempt to puncture to the successful one in seconds | During the procedure | |
Secondary | Puncture Attempts | Which is the number of puncture attempts from first one until the successful one (maximum 6) | During the procedure | |
Secondary | Procedure Duration | In minutes from the insertion of the sheath to its exertion. | During the procedure | |
Secondary | Radiation Duration | Which is measured by the radiological device in minutes. | During the procedure | |
Secondary | Radiology Dose | Which is measured by the radiological device in mGy. | During the procedure | |
Secondary | Compression "hemostasis" time | The time from the placement of the compression band until its removal (when there's no blood oozing after deflation), measured by minutes. | Up to 240 minutes after band placement | |
Secondary | Arterial spasm | Which is assessed by the operator if present or absent in terms of the difficulty in inserting the wire at the time of the procedures.
of the procedure. |
During the procedure | |
Secondary | Hematoma and bleeding complications | It is defined by EASY hematoma scale. | Within 24 hours after the procedure | |
Secondary | Ischemic changes to the hand | It is noted by clinical features of pallor, absence of pulse, pain, cold, paresthesia or paralysis. | Within 24 hours after the procedure | |
Secondary | Crossover (failure to puncture) | It is transforming from the selected access to another after 6 failed attempts to puncture the first selected access | During the procedure | |
Secondary | Procedural pain | Assessed by numerical rating scale (NRS) for pain, which is an 10 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain. | During the procedure | |
Secondary | Post-procedural pain | Assessed by numerical rating scale (NRS) for pain, which is an 11 point subjective scale (0-10) where 0 refers for no pain, 1-3 for mild pain, 4-6 for moderate pain and 7-10 for severe pain. | Within 24 hours after the procedure | |
Secondary | Rare complications | Pseudo-aneurysm, AV fistula formation, radial artery dissection, which are assessed by Doppler US. In addition to radial artery eversion or perforation. | Within 24 hours after the procedure | |
Secondary | Radial Artery Occlusion on follow up | Follow up Doppler Ultrasonography for patients with occluded radial artery within 24 hours. | After 2 weeks of the procedure. |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06030596 -
SPECT Myocardial Blood Flow Quantification for Diagnosis of Ischemic Heart Disease Determined by Fraction Flow Reserve
|
||
Completed |
NCT04080700 -
Korean Prospective Registry for Evaluating the Safety and Efficacy of Distal Radial Approach (KODRA)
|
||
Recruiting |
NCT03810599 -
Patient-reported Outcomes in the Bergen Early Cardiac Rehabilitation Study
|
N/A | |
Recruiting |
NCT06002932 -
Comparison of PROVISIONal 1-stent Strategy With DEB Versus Planned 2-stent Strategy in Coronary Bifurcation Lesions.
|
N/A | |
Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
Recruiting |
NCT05308719 -
Nasal Oxygen Therapy After Cardiac Surgery
|
N/A | |
Recruiting |
NCT04242134 -
Drug-coating Balloon Angioplasties for True Coronary Bifurcation Lesions
|
N/A | |
Completed |
NCT04556994 -
Phase 1 Cardiac Rehabilitation With and Without Lower Limb Paddling Effects in Post CABG Patients.
|
N/A | |
Recruiting |
NCT05846893 -
Drug-Coated Balloon vs. Drug-Eluting Stent for Clinical Outcomes in Patients With Large Coronary Artery Disease
|
N/A | |
Recruiting |
NCT06027788 -
CTSN Embolic Protection Trial
|
N/A | |
Recruiting |
NCT05023629 -
STunning After Balloon Occlusion
|
N/A | |
Completed |
NCT04941560 -
Assessing the Association Between Multi-dimension Facial Characteristics and Coronary Artery Diseases
|
||
Completed |
NCT04006288 -
Switching From DAPT to Dual Pathway Inhibition With Low-dose Rivaroxaban in Adjunct to Aspirin in Patients With Coronary Artery Disease
|
Phase 4 | |
Completed |
NCT01860274 -
Meshed Vein Graft Patency Trial - VEST
|
N/A | |
Recruiting |
NCT06174090 -
The Effect of Video Education on Pain, Anxiety and Knowledge Levels of Coronary Bypass Graft Surgery Patients
|
N/A | |
Terminated |
NCT03959072 -
Cardiac Cath Lab Staff Radiation Exposure
|
||
Completed |
NCT03968809 -
Role of Cardioflux in Predicting Coronary Artery Disease (CAD) Outcomes
|
||
Recruiting |
NCT05065073 -
Iso-Osmolar vs. Low-Osmolar Contrast Agents for Optical Coherence Tomography
|
Phase 4 | |
Recruiting |
NCT04566497 -
Assessment of Adverse Outcome in Asymptomatic Patients With Prior Coronary Revascularization Who Have a Systematic Stress Testing Strategy Or a Non-testing Strategy During Long-term Follow-up.
|
N/A | |
Completed |
NCT05096442 -
Compare the Safety and Efficacy of Genoss® DCB and SeQuent® Please NEO in Korean Patients With Coronary De Novo Lesions
|
N/A |