Trial Outcomes & Findings for Mechanochemical Ablation Compared to Cyanoacrylate Adhesive (NCT NCT03392753)

NCT ID: NCT03392753

Last Updated: 2022-08-04

Results Overview

Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 167 participants
• Primary outcome timeframe: On day 0 immediately following vein ablation
• Results posted on: 2022-08-04

Participant Flow

Recruitment period: November 2017 and February 2020 Recruitment location: 1. Charing Cross Hospital (Imperial College Healthcare NHS Trust) in London, UK; 2. Singapore General Hospital; 3. Sengkang General Hospital (Singapore)

167 patients recruited

Participant milestones

Measure	Mechanochemical Ablation (MOCA) Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Overall Study STARTED	83	84
Overall Study COMPLETED	47	50
Overall Study NOT COMPLETED	36	34

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Mechanochemical Ablation (MOCA) n=83 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=84 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)	Total n=167 Participants Total of all reporting groups
Age, Continuous	57 years STANDARD_DEVIATION 16 • n=83 Participants	55 years STANDARD_DEVIATION 15 • n=84 Participants	56 years STANDARD_DEVIATION 15 • n=167 Participants
Sex: Female, Male Female	53 Participants n=83 Participants	46 Participants n=84 Participants	99 Participants n=167 Participants
Sex: Female, Male Male	30 Participants n=83 Participants	38 Participants n=84 Participants	68 Participants n=167 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United Kingdom	50 participants n=83 Participants	50 participants n=84 Participants	100 participants n=167 Participants
Region of Enrollment Singapore	33 participants n=83 Participants	34 participants n=84 Participants	67 participants n=167 Participants

PRIMARY outcome

Timeframe: On day 0 immediately following vein ablation

Pain score during saphenous vein ablation using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=83 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=84 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Pain Score During Ablation	24 Units on a scale Interval 24.0 to 44.7	20 Units on a scale Interval 9.0 to 42.0

SECONDARY outcome

Timeframe: On day 0 following vein ablation and any tributary treatment

Pain score at the end of the procedure using a 0-100mm visual analogue scale (0=no pain; 100=worst pain)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=83 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=84 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Pain Score at the End of the Procedure	8 Units on a scale Interval 3.0 to 22.0	11 Units on a scale Interval 4.0 to 27.0

SECONDARY outcome

Timeframe: Recorded at 12 months

Using the EuroQoL's EQ-5D questionnaire (-0.085=worse quality of life; 1.000=best quality of life)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=47 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=50 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Generic Quality of Life as Per EQ-5D Questionnaire	1 score on a scale Interval 0.74 to 1.0	1 score on a scale Interval 0.73 to 1.0

SECONDARY outcome

Timeframe: Recorded at 12 months

Using the Aberdeen Varicose Vein Questionnaire (AVVQ) questionnaire (0=best quality of life; 100=worse quality of life)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=47 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=50 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Disease Specific Quality of Life as Per the AVVQ	4 score on a scale Interval 0.0 to 11.9	5.9 score on a scale Interval 1.4 to 13.4

SECONDARY outcome

Timeframe: 12 months

Using the CIVIQ-20 questionnaire (0=best quality of life; 100=worse quality of life)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=47 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=50 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Disease Specific Quality of Life as Per the CIVIQ-20	3.5 score on a scale Interval 0.0 to 20.0	7.1 score on a scale Interval 0.75 to 21.4

SECONDARY outcome

Timeframe: 12 months

Using the Venous Clinical Severity Score (VCSS) (0=best; 30=worse)

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=47 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=50 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Clinical Change as Per VCSS	2 score on a scale Interval 1.0 to 3.0	2 score on a scale Interval 1.0 to 3.0

SECONDARY outcome

Timeframe: For the first 10 days since procedure

Pain score over the first 10 days using a 0-100mm visual analogue scale (0=no pain; 100=worst pain). The mean pain score was recorded daily and a mean value was calculated.

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=47 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=50 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Pain Score Over the First 10 Days	10.5 Units on a scale Interval 3.0 to 16.0	7 Units on a scale Interval 2.5 to 19.0

SECONDARY outcome

Timeframe: 2 weeks

Degree of bruising at 2 weeks using a categorical 0-5 bruising scale (0=no bruising; 5=bruising extending beyond treated segment). The outcome measured is the number of participants with a degree of bruising between category 0-1.

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=59 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=71 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Degree of Bruising at 2 Weeks	53 participants	59 participants

SECONDARY outcome

Timeframe: 2 weeks

Length of time in days until normal activities are resumed

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=71 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=77 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Time to Return to Normal Activities	7 days Interval 4.0 to 10.0	8.5 days Interval 4.0 to 10.0

SECONDARY outcome

Timeframe: 12 months

Rate of occlusion as assessed by duplex ultrasound

Outcome measures

Measure	Mechanochemical Ablation (MOCA) n=33 Participants Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=34 Participants Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Occlusion Rates	29 Participants	31 Participants

Adverse Events

Mechanochemical Ablation (MOCA)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cyanoacrylate Adhesive (CAE)

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Mechanochemical Ablation (MOCA) n=83 participants at risk Mechanochemical ablation using the ClariVein® mechanochemical ablation (MOCA) device (Vascular Insights, Madison, CT, USA). Mechanochemical ablation: Treatment of incompetent saphenous veins using mechanochemical ablation (Clarivein)	Cyanoacrylate Adhesive (CAE) n=84 participants at risk Cyanoacrylate using the VenaSealTM Closure System (Medtronic, Minneapolis, Minnesota, USA). Cyanoacrylate adhesive: Treatment of incompetent saphenous veins using cyanoacrylate (VenaSealTM)
Vascular disorders Phlebitis	0.00% 0/83 • 12 months	2.4% 2/84 • Number of events 2 • 12 months

Additional Information

Mr Roshan Bootun

Imperial College London

Phone: +442033117335

Email: r.bootun@imperial.ac.uk

Results disclosure agreements

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