Trial Outcomes & Findings for Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation (NCT NCT03381989)

NCT ID: NCT03381989

Last Updated: 2021-03-18

Results Overview

Successful BASILICA traversal and laceration; immediate survival; successful first TAVR device implantation; absence of coronary artery obstruction; and freedom from emergency cardiac surgery or reintervention related to the BASILICA or TAVR procedure.

Recruitment status

COMPLETED

Study phase

Target enrollment

31 participants

Primary outcome timeframe

1 day

Results posted on

2021-03-18

Participant Flow

31 participants enrolled on protocol. 30 started the protocol, after 1 participant withdrew consent prior to the procedure.

Participant milestones

Participant milestones
Measure	Single Arm: Open-label Treatment The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Overall Study STARTED	30
Overall Study COMPLETED	22
Overall Study NOT COMPLETED	8

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Bioprosthetic or Native Aortic Scallop Intentional Laceration to Prevent Iatrogenic Coronary Artery Obstruction (BASILICA) Prospective Investigation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Single Arm: Open-label Treatment n=30 Participants The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	25 Participants n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	28 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 day

Population: Subjects who underwent the BASILICA procedure

Outcome measures

Outcome measures
Measure	Single Arm: Open-label Treatment n=30 Participants The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Number of Participants With Procedure Success, Measured at Exit From the Catheterization Laboratory	28 participants

PRIMARY outcome

Timeframe: 30 days

Population: Subjects who underwent the BASILICA procedure

Freedom from major adverse clinical events (MACE) according to Valve Academic Research Consortium (VARC-2) at 30days.

Outcome measures

Outcome measures
Measure	Single Arm: Open-label Treatment n=30 Participants The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Number of Participants Were Safety Endpoint is Freedom From Major Adverse Clinical Events (MACE)	21 Participants

Adverse Events

Single Arm: Open-label Treatment

Serious events: 13 serious events

Other events: 0 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Single Arm: Open-label Treatment n=30 participants at risk The BASILICA procedure has three steps: (1) leaflet traversal with a guidewire, followed by (2) leaflet laceration, immediately followed by (3) TAVR.
Cardiac disorders Cardiac pacemaker insertion	6.7% 2/30 • 12 months
Cardiac disorders Hemodynamic instability from lacertation requiring vasopressors	6.7% 2/30 • 12 months
Cardiac disorders Secondary myocardial infarction	3.3% 1/30 • 12 months
Injury, poisoning and procedural complications Life threatening bleeding	6.7% 2/30 • 12 months
Injury, poisoning and procedural complications Major vascular complication	20.0% 6/30 • 12 months
Nervous system disorders Ischemic stroke	10.0% 3/30 • 12 months
Renal and urinary disorders AKI - Acute Kidney Injury Stage 2/3	3.3% 1/30 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Lederman, Robert

National Heart Lung and Blood Institute

Phone: +1 301 402 6769

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place