Trial Outcomes & Findings for RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT) (NCT NCT01297322)
NCT ID: NCT01297322
Last Updated: 2020-01-22
Results Overview
Primary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
COMPLETED
NA
420 participants
Up to 1 hour
2020-01-22
Participant Flow
Participant milestones
| Measure |
Manual Compression
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Overall Study
STARTED
|
142
|
278
|
|
Overall Study
COMPLETED
|
141
|
274
|
|
Overall Study
NOT COMPLETED
|
1
|
4
|
Reasons for withdrawal
| Measure |
Manual Compression
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
|
Overall Study
Protocol Violation
|
0
|
3
|
Baseline Characteristics
RESPECT Trial - (Rapid Extravascular Sealing Via PercutanEous Collagen ImplanT)
Baseline characteristics by cohort
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
Total
n=417 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.5 years
STANDARD_DEVIATION 10.4 • n=5 Participants
|
61.8 years
STANDARD_DEVIATION 11.2 • n=7 Participants
|
62 years
STANDARD_DEVIATION 10.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
41 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
120 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
101 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
297 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
130 Participants
n=5 Participants
|
249 Participants
n=7 Participants
|
379 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 1 hourPrimary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and first observed and confirmed arterial hemostasis.
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Time to Hemostasis (TTH)
|
21.4 minutes
Standard Deviation 12.4
|
4.8 minutes
Standard Deviation 5.4
|
PRIMARY outcome
Timeframe: 30 days +/- 7 daysPrimary safety endpoint * Access site-related bleeding requiring transfusion; * Vascular injury requiring repair (via surgery, ultrasound guided compression, transcatheter embolization or stent graft); * New ipsilateral lower extremity ischemia causing a threat to the viability of the limb and requiring surgical or additional percutaneous intervention. This compromised blood flow is documented by subject symptoms, physical exam and/or a decreased or absent blood flow on lower extremity angiogram.; * Access site-related infection requiring intravenous antibiotics and/or extended hospitalization; * New onset access site-related neuropathy in the ipsilateral lower extremity requiring surgical repair; * Permanent access site-related nerve injury. (\> 30 days)
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Rate of Combined Access Site-related Major Complications
|
0 participants
|
0 participants
|
SECONDARY outcome
Timeframe: Up to 1 daySecondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject stands and walks 20 feet without evidence of arterial re-bleeding
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Time to Ambulation (TTA)
|
5.8 hours
Standard Deviation 3.1
|
3.8 hours
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: Up to 2 daysSecondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is medically able to be discharged based solely on the assessment of the access site, as determined by the medical team
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=274 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Time to Discharge Eligibility (TTDE)
|
6.5 hours
Standard Deviation 3.3
|
4.8 hours
Standard Deviation 6.4
|
SECONDARY outcome
Timeframe: Up to 2 daysSecondary effectiveness endpoint - elapsed time between device (VASCADE) or sheath (manual compression) removal and when subject is actually discharged from the hospital
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Time to Hospital Discharge (TTHD)
|
13.7 hours
Standard Deviation 9.8
|
18.3 hours
Standard Deviation 34.5
|
SECONDARY outcome
Timeframe: Up to 1 daySecondary effectiveness endpoint - ability to deploy the delivery system, deliver the collagen, and achieve hemostasis with VASCADE alone or with adjunctive compression
Outcome measures
| Measure |
Manual Compression
n=275 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Device Success
|
263 participants
|
—
|
SECONDARY outcome
Timeframe: 30 days +/- 7 daysSecondary effectiveness endpoint - attainment of final hemostasis using any method and freedom from major vascular complications through 30 days
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Procedure Success
|
142 participants
|
275 participants
|
SECONDARY outcome
Timeframe: 30 days +/- 7 daysSecondary safety endpoint * Access site-related bleeding requiring greater than 30 minutes to achieve hemostasis; * Access site-related hematoma \> 6 cm; * Late access site-related bleeding (following hospital discharge); * Ipsilateral lower extremity arterial emboli; * Ipsilateral deep vein thrombosis; * Access site-related vessel laceration; * Access site wound dehiscence; * Localized access site infection treated with intramuscular or oral antibiotics; * Arteriovenous fistula not requiring treatment; * Pseudoaneurysm requiring thrombin injection or fibrin adhesive injection; * Pseudoaneurysm not requiring treatment; * New onset access site-related neuropathy in the ipsilateral lower extremity not requiring surgical repair; * Ipsilateral pedal pulse diminished by two grades or transiently lost.
Outcome measures
| Measure |
Manual Compression
n=142 Participants
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 Participants
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Rate of Combined Minor Access Site Complications
|
10 participants
|
3 participants
|
Adverse Events
Manual Compression
VASCADE™ Vascular Closure System
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Manual Compression
n=142 participants at risk
Manual compression: Standard of Care
|
VASCADE™ Vascular Closure System
n=275 participants at risk
Cardiva VASCADE™ Vascular Closure System: Investigational Hemostatic Vascular Closure System
|
|---|---|---|
|
Psychiatric disorders
Altered mental status
|
0.00%
0/142 • 30 days
|
1.5%
4/275 • Number of events 4 • 30 days
|
|
Surgical and medical procedures
Access site-related tissue tract oozing - prolonged
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Cardiac disorders
Angina
|
0.70%
1/142 • Number of events 1 • 30 days
|
1.1%
3/275 • Number of events 3 • 30 days
|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/142 • 30 days
|
1.5%
4/275 • Number of events 4 • 30 days
|
|
Cardiac disorders
Cardiac disorders/symptoms
|
0.00%
0/142 • 30 days
|
1.1%
3/275 • Number of events 3 • 30 days
|
|
Skin and subcutaneous tissue disorders
Dermatologic disorders / symptoms
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.73%
2/275 • Number of events 2 • 30 days
|
|
Surgical and medical procedures
Discomfort - access site
|
0.00%
0/142 • 30 days
|
2.2%
6/275 • Number of events 6 • 30 days
|
|
General disorders
Discomfort - nonaccess site
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.00%
0/275 • 30 days
|
|
General disorders
Dizziness
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Ear and labyrinth disorders
ENT disorders/symptoms
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Ecchymosis - access site
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Ecchymosis - nonaccess site
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Skin and subcutaneous tissue disorders
Erythema - access site
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
General disorders
Fall
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Gastrointestinal disorders
GI disorders/symptoms
|
2.8%
4/142 • Number of events 4 • 30 days
|
1.8%
5/275 • Number of events 5 • 30 days
|
|
Renal and urinary disorders
GU disorders/symptoms
|
0.00%
0/142 • 30 days
|
0.73%
2/275 • Number of events 2 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
General disorder/respiratory
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.00%
0/275 • 30 days
|
|
General disorders
General disorders/symptoms
|
1.4%
2/142 • Number of events 2 • 30 days
|
1.5%
4/275 • Number of events 4 • 30 days
|
|
General disorders
Headache
|
2.8%
4/142 • Number of events 4 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Nervous system disorders
Neurological deficit - TIA
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Musculoskeletal and connective tissue disorders
Ortho disorders/symptoms
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.00%
0/275 • 30 days
|
|
General disorders
Pain - access site
|
2.1%
3/142 • Number of events 3 • 30 days
|
0.73%
2/275 • Number of events 2 • 30 days
|
|
General disorders
Pain - nonaccess site
|
1.4%
2/142 • Number of events 2 • 30 days
|
2.2%
6/275 • Number of events 6 • 30 days
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.70%
1/142 • Number of events 1 • 30 days
|
1.1%
3/275 • Number of events 3 • 30 days
|
|
Renal and urinary disorders
Renal failure/insufficiency
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory disorders/symptoms
|
0.00%
0/142 • 30 days
|
1.5%
4/275 • Number of events 4 • 30 days
|
|
Injury, poisoning and procedural complications
Retroperitoneal bleeding (hematoma/hemorrhage)
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
General disorders
Swelling - nonaccess site
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Vascular disorders
Vascular repair - non-device related
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Nervous system disorders
Vasovagal episode
|
1.4%
2/142 • Number of events 2 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Cardiac disorders
Ventricular arrhythmia
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Hematoma - access site
|
1.4%
2/142 • Number of events 2 • 30 days
|
2.2%
6/275 • Number of events 6 • 30 days
|
|
Renal and urinary disorders
Hematuria
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Cardiac disorders
Hypertension
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Blood and lymphatic system disorders
Hypervolemia
|
0.00%
0/142 • 30 days
|
0.73%
2/275 • Number of events 2 • 30 days
|
|
Cardiac disorders
Hypotension
|
0.70%
1/142 • Number of events 1 • 30 days
|
1.1%
3/275 • Number of events 3 • 30 days
|
|
Infections and infestations
Infection - access site
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Nervous system disorders
Neuro - other
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.73%
2/275 • Number of events 2 • 30 days
|
|
Vascular disorders
Arterial Thrombosis - peripheral/ non-access site-related
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Vascular disorders
Embolization - peripheral non-access site-related
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Cardiac disorders
Severe Hypotension Requiring Treatment
|
0.00%
0/142 • 30 days
|
1.1%
3/275 • Number of events 3 • 30 days
|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/142 • 30 days
|
0.36%
1/275 • Number of events 1 • 30 days
|
|
Renal and urinary disorders
Renal Insufficiency
|
0.70%
1/142 • Number of events 1 • 30 days
|
0.00%
0/275 • 30 days
|
|
Blood and lymphatic system disorders
Access site re-bleeding after initial hemostasis confirmed for 5 minutes
|
2.8%
4/142 • Number of events 4 • 30 days
|
2.5%
7/275 • Number of events 7 • 30 days
|
Additional Information
Michael A. Daniel, Consulting VP Regulatory Affairs
Daniel & Daniel Consulting, LLC
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place