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AMBULATE EARLY TRAIL

A Prospective Trail Comparing Safety and Efficacy of Collagen based vs Suture based Vascular Closure Device and Manual Compression in Patients who have Undergone Femoral Artery Puncture Interventional Procedure

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/05/025285
Enrollment
200
Registered
2020-05-21
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I209- Angina pectoris, unspecified

Interventions

Intervention1: Vascular closure device - collagen based vs suture based: Vascular closure device are used to seal the puncture site after femoral artery puncture based interventions and this allows ea

Sponsors

Rohit Walia
Lead Sponsor
Meril Life Science Private Limited
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: Age greater than 18 years , valid informed consent , posted for femoral artery puncture based diagnostic or interventional procedure

Exclusion criteria

Exclusion criteria: vascular graft or a re-puncture at a site previously punctured within 48 hours or planned arterial access at the same access site within 30 days of catheterisation bleeding disorder , significant anemia allergy to bovine materials, collagen and/or collagen products, or polyglycolic or polylactic acid polymers. Patients undergoing thrombolytic therapy or treated with Warfarin within 24 hours prior to catheterization. Patients who are known or suspected to be pregnant or is lactating. Patients with uncontrolled hypertension with systolic blood pressure greater than 180 mmHg, unless systolic pressure can be lowered by pharmacological agents prior to closure. Peripheral vascular disease

Design outcomes

Primary

MeasureTime frame
Time to HaemostasisTimepoint: Time to Haemostasis

Secondary

MeasureTime frame
Time to ambulation, patient satisfaction, and vascular complications are secondary endpoints.Timepoint: Day 2

Countries

India

Contacts

Public ContactDr Rohit Walia

All India Institute. of Medical Science , Rishikesh

rwalia7731@yahoo.in8800492549

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026