NCT03854253 (IntroLength) is a NA clinical trial of Long introducer sheath in Coronary Artery Disease, sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences.

Who is sponsoring NCT03854253?

NCT03854253 is sponsored by Tomsk National Research Medical Center of the Russian Academy of Sciences.

What drugs are being tested in NCT03854253?

Interventions in NCT03854253: Long introducer sheath, Short introducer sheath.

What condition does NCT03854253 study?

NCT03854253 studies Coronary Artery Disease.

Is NCT03854253 still recruiting?

NCT03854253 is currently completed. Last updated 13 January 2020.

Are results published for NCT03854253?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2020-01-13 · How we verify

NCT03854253: IntroLength

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Effect of Introducer Length on the Rate of Radial Artery Occlusion During Endovascular Coronary Procedures

Completed NA Results posted Last updated 13 January 2020

What this trial tests

NA trial testing Long introducer sheath in Coronary Artery Disease in 100 participants. Completed in 14 March 2019.

Timeline

26 February 2019

Primary endpoint
13 March 2019

14 March 2019

Quick facts

Lead sponsor	Tomsk National Research Medical Center of the Russian Academy of Sciences
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	prevention
Enrollment	100
Start date	26 February 2019
Primary completion	13 March 2019
Estimated completion	14 March 2019
Sites	1 location across Russia

Drugs / interventions tested

Long introducer sheath
Short introducer sheath

Conditions studied

Coronary Artery Disease — all drugs for Coronary Artery Disease →

Sponsor

Tomsk National Research Medical Center of the Russian Academy of Sciences

Who can join

18 and older, any sex, with Coronary Artery Disease. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Radial Artery Occlusion Primary · up to 10 days

Participants who diagnosed a radial artery occlusion with color Doppler ultrasound.

Group	Value	95% CI
Long Introducer 6Fr-25cm	4
Short Introducer 6Fr-10cm	2

Number of Participants With a Hematoma, Stage I Secondary · up to 10 days

Rate of access site complications during percutaneous procedures performed via a transradial approach. Local hematomas are classified according to the following scale: I - diameter not more than 5 cm, II - not more than 10 cm, III - not more than 10 cm, but not higher than the elbow, IV - above the elbow, V - with the threat of hand ischemia \[Bertrand, O. F., De Larochelliere, R., Rodes-Cabau, J., Proulx, G., Gleeton, O., Manh Nguyen, C., Dery J.P., Barbeau G., Noel B., Larose E., Poirier P., Roy L. A Randomized Study Comparing Same-Day Home Discharge and Abciximab Bolus Only to Overnight Hos

Group	Value	95% CI
Long Introducer 6Fr-25cm	8
Short Introducer 6Fr-10cm	8

Rate of Conversion of Needle Type Secondary · up to 10 days

Rate of conversion type of Needle type during percutaneous procedures performed via a transradial approach.

Group	Value	95% CI
Long Introducer 6Fr-25cm	5
Short Introducer 6Fr-10cm	0

Time of the Introducer Insertion Secondary · up to 10 days

Time from start punction of the radial artery to full insertion of the introducer

Group	Value	95% CI
Long Introducer 6Fr-25cm	94	67.5 – 162.5
Short Introducer 6Fr-10cm	42.5	33 – 65.3

Time of the Procedure Secondary · up to 10 days

Time from insertion of the introducer to finish the procedure

Group	Value	95% CI
Long Introducer 6Fr-25cm	448	337.5 – 633
Short Introducer 6Fr-10cm	350.5	307 – 506.8

Fluoroscopy Time Secondary · up to 10 days

Fluoroscopy time, sec

Group	Value	95% CI
Long Introducer 6Fr-25cm	82.0	48.5 – 133.0
Short Introducer 6Fr-10cm	69.5	48.0 – 118.3

Total Air Kerma Secondary · up to 10 days

Total air kerma, mGy

Group	Value	95% CI
Long Introducer 6Fr-25cm	140.8	± 97.7
Short Introducer 6Fr-10cm	128.2	± 71.3

Number of Participants With a Perforation / Dissection of a Radial Artery. Secondary · up to 10 days

Rate of access site complications during percutaneous procedures performed via a transradial approach

Group	Value	95% CI
Long Introducer 6Fr-25cm	0
Short Introducer 6Fr-10cm	0

Number of Participants With Median Nerve Neuritis Secondary · up to 10 days

Rate of access site complications during percutaneous procedures performed via a transradial approach

Group	Value	95% CI
Long Introducer 6Fr-25cm	0
Short Introducer 6Fr-10cm	0

Number of Participants With a Bleeding of the Puncture Site. Secondary · up to 10 days

Rate of access site complications during percutaneous procedures performed via a transradial approach.

Group	Value	95% CI
Long Introducer 6Fr-25cm	1
Short Introducer 6Fr-10cm	0

Sponsor's own description

This study evaluates estimate impact of introducers length during endovascular coronary procedures on rate of a radial artery occlusion. For half of participants will use short introducers, while for other will use long introducers during transradial coronary intervention.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

Other recruiting trials for Coronary Artery Disease

Currently open trials in the same condition.

NCT07399002 — LONG NAGOMI™ PMCF STUDY · recruiting
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NCT06535568 — Single vs. Dual Antiplatelet Therapy in Elderly or HBR Patients Undergoing Percutaneous Intervention With DCB (PICCOLETO · NA · recruiting
NCT07286578 — A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Under · NA · recruiting

Other Tomsk National Research Medical Center of the Russian Academy of Sciences trials

Trials by the same sponsor.

NCT07457541 — Molecular Imaging of Fibroblast Activation Protein Expression Using Labeled Technetium-99m HYNIC-FAPI · Phase 1 · active not recruiting
NCT07475390 — 99mTc-1-thio-D-glucose SPECT/CT Versus 18F-Fluoroethyl-l-tyrosine PET/CT in Brain Tumor Imaging · NA · active not recruiting
NCT07292571 — Evaluation of Different Types of HER2 Expression in Breast Cancer Using [99mTc]Tc -ZHER2:4107 · Phase 2 · enrolling by invitation
NCT07275463 — [99mTc]Tc-DB8 Accumulation in Primary Tumor in Breast Cancer With Positive and Negative Estrogen Receptor Expression · Phase 2 · enrolling by invitation
NCT07018895 — Personalized Hypoxic-hyperoxic Preconditioning in Elderly People · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03854253 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Tomsk National Research Medical Center of the Russian Academy of Sciences
Last refreshed: 13 January 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03854253.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing