Trial Outcomes & Findings for The Merit WRAPSODY™ Endovascular Stent Graft (NCT NCT03644017)

NCT ID: NCT03644017

Last Updated: 2022-01-21

Results Overview

The total number of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 46 participants
• Primary outcome timeframe: 30 days
• Results posted on: 2022-01-21

Participant Flow

Participant milestones

Measure	WRAPSODY Stent Graft All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Overall Study STARTED	46
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	7

Reasons for withdrawal

Measure	WRAPSODY Stent Graft All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Overall Study Access Abandonment	5
Overall Study Kidney Transplant	2

Baseline Characteristics

The Merit WRAPSODY™ Endovascular Stent Graft

Baseline characteristics by cohort

Measure	WRAPSODY Stent Graft n=46 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Age, Continuous	66.7 years STANDARD_DEVIATION 12.87 • n=5 Participants
Sex: Female, Male Female	24 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	45 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 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	4 Participants n=5 Participants
Race (NIH/OMB) White	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Greece	23 participants n=5 Participants
Region of Enrollment United Kingdom	23 participants n=5 Participants

PRIMARY outcome

Timeframe: 30 days

The total number of subjects without any localized or systemic safety events through 30 days that affect the access or venous outflow circuit and resulted in surgery, hospitalization, or death

Outcome measures

Measure	WRAPSODY Stent Graft n=46 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants Without Any Localized or Systemic Safety Events Through 30 Days	45 Participants

PRIMARY outcome

Timeframe: 30 days

The total number of subjects with Target Lesion Primary Patency at 30 days

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Target Lesion Primary Patency at 30 Days	45 Participants

SECONDARY outcome

Timeframe: 3 months

The total number of subjects with Target Lesion Primary Patency at 3 months

Outcome measures

Measure	WRAPSODY Stent Graft n=44 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Target Lesion Primary Patency at 3 Months	44 Participants

SECONDARY outcome

Timeframe: 6 months

The total number of subjects with Target Lesion Primary Patency at 6 months

Outcome measures

Measure	WRAPSODY Stent Graft n=43 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Target Lesion Primary Patency at 6 Months	42 Participants

SECONDARY outcome

Timeframe: 12 months

The total number of subjects with Target Lesion Primary Patency at 12 months

Outcome measures

Measure	WRAPSODY Stent Graft n=39 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Target Lesion Primary Patency at 12 Months	33 Participants

SECONDARY outcome

Timeframe: 30 days

The total number of subjects with Assisted Primary Patency of the Target Lesion at 30 days

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Target Lesion Primary Patency at 30 Days	45 Participants

SECONDARY outcome

Timeframe: 3 months

The total number of subjects with Assisted Primary Patency of the Target Lesion at 3 months

Outcome measures

Measure	WRAPSODY Stent Graft n=44 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Target Lesion Primary Patency at 3 Months	44 Participants

SECONDARY outcome

Timeframe: 6 months

The total number of subjects with Assisted Primary Patency of the Target Lesion at 6 months

Outcome measures

Measure	WRAPSODY Stent Graft n=43 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Target Lesion Primary Patency at 6 Months	43 Participants

SECONDARY outcome

Timeframe: 12 months

The total number of subjects with Assisted Primary Patency of the Target Lesion at 12 months

Outcome measures

Measure	WRAPSODY Stent Graft n=39 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Target Lesion Primary Patency at 12 Months	39 Participants

SECONDARY outcome

Timeframe: 30 days

The total number of subjects with Access Circuit Primary Patency at 30 days

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Access Circuit Primary Patency at 30 Days	43 Participants

SECONDARY outcome

Timeframe: 3 months

The total number of subjects with Access Circuit Primary Patency at 3 months

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Access Circuit Primary Patency at 3 Months	40 Participants

SECONDARY outcome

Timeframe: 6 months

The total number of subjects with Access Circuit Primary Patency at 6 months

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Access Circuit Primary Patency at 6 Months	38 Participants

SECONDARY outcome

Timeframe: 12 months

The total number of subjects with Access Circuit Primary Patency at 12 months

Outcome measures

Measure	WRAPSODY Stent Graft n=44 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Access Circuit Primary Patency at 12 Months	29 Participants

SECONDARY outcome

Timeframe: 30 days

The total number of subjects with Assisted Access Circuit Primary Patency at 30 days

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Access Circuit Primary Patency at 30 Days	45 Participants

SECONDARY outcome

Timeframe: 3 months

The total number of subjects with Assisted Access Circuit Primary Patency at 3 months

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Access Circuit Primary Patency at 3 Months	44 Participants

SECONDARY outcome

Timeframe: 6 months

The total number of subjects with Assisted Access Circuit Primary Patency at 6 months

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Access Circuit Primary Patency at 6 Months	43 Participants

SECONDARY outcome

Timeframe: 12 months

The total number of subjects with Assisted Access Circuit Primary Patency at 12 months

Outcome measures

Measure	WRAPSODY Stent Graft n=44 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Assisted Access Circuit Primary Patency at 12 Months	39 Participants

SECONDARY outcome

Timeframe: 30 days

The resumption of successful dialysis through existing access for at least one session following the initial study procedure

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Clinical Success	45 Participants

SECONDARY outcome

Timeframe: Immediately following the study procedure

Less than 30% residual stenosis immediately following the study procedure

Outcome measures

Measure	WRAPSODY Stent Graft n=46 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Anatomic Success	46 Participants

SECONDARY outcome

Timeframe: 30 days

The achievement of both clinical and anatomic success

Outcome measures

Measure	WRAPSODY Stent Graft n=45 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Procedural Success	45 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 12 months

Total number of participants (subset of subjects with thoracic central venous target lesions only) with freedom from stent graft fracture, defined as clear interruption of a stent strut observed in a minimum of two projections taken during the 12 month visit or after determined by DMC/CEC examination of X-Ray images.

Outcome measures

Measure	WRAPSODY Stent Graft n=8 Participants All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Number of Participants With Stent Graft Integrity (Subset of Subjects With Thoracic Central Venous Target Lesions Only)	8 Participants

Adverse Events

WRAPSODY Stent Graft

Serious events: 10 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	WRAPSODY Stent Graft n=46 participants at risk All subjects will receive treatment via WRAPSODY Stent Graft Placement. WRAPSODY Stent Graft Placement: The stent graft will be placed into a target lesion (stenosis or occlusion) of a vein
Infections and infestations Pneumonia	6.5% 3/46 • Number of events 3 • 12 months
Injury, poisoning and procedural complications Arteriovenous fistula thrombosis	4.3% 2/46 • Number of events 2 • 12 months
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.2% 1/46 • Number of events 2 • 12 months
Cardiac disorders Myocardial infarction	2.2% 1/46 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Arteriovenous graft thrombosis	4.3% 2/46 • Number of events 2 • 12 months
Injury, poisoning and procedural complications Extradural haematoma	2.2% 1/46 • Number of events 1 • 12 months
Product Issues Device dislocation	2.2% 1/46 • Number of events 1 • 12 months
Injury, poisoning and procedural complications Fall	2.2% 1/46 • Number of events 1 • 12 months
Blood and lymphatic system disorders Anaemia	2.2% 1/46 • Number of events 1 • 12 months
Investigations Coronavirus test positive	2.2% 1/46 • Number of events 1 • 12 months
Renal and urinary disorders Renal failure	2.2% 1/46 • Number of events 1 • 12 months
Cardiac disorders Acute myocardial infarction	2.2% 1/46 • Number of events 1 • 12 months

Other adverse events

Adverse event data not reported

Additional Information

Casey Holland, Senior Director Clinical Operations

Merit Medical Systems, Inc.

Phone: +1 (617) 842-0251

Email: casey.holland@merit.com

Results disclosure agreements

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

Restriction type: GT60