Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

Coronary Occlusion Clinical Trial

Official title:

Randomized Comparative Study Between Intravascular Ultrasonography Guided and Angiography-guided Recanalization of Coronary Chronic Total Occlusions

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03159650
• Other study ID #: IVUSAN
• Status: Not yet recruiting
• Phase: N/A
• First received: May 17, 2017
• Last updated: May 17, 2017
• Start date: June 1, 2017
• Est. completion date: October 1, 2019

Study information

• Verified date: May 2017
• Source: Assiut University
• Contact: Hosam Hasan, professor
• Phone: +20882361015
• Email: hosam_hasan[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Chronic total occlusion is defined as thrombolysis in myocardial infarction (TIMI) flow grade 0 with an estimated duration of at least 3 months. The interest in chronic total occlusion (CTO) percutaneous coronary intervention (PCI) has increased, but with failure rate up to 20%, leading to important developments in dedicated equipment and techniques.

In the 2014 European Guidelines on Myocardial Revascularization, intravascular ultrasound was recommended to guide stent implantation in selected patients, and this recommendation was a class IIa/level of evidence B.

In CTO PCI, certain angiographic features such as blunt proximal CTO cap, tortuosity, heavy calcification, and lack of visibility of path in the distal vessel increase procedural difficulty

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 80
• Est. completion date: October 1, 2019
• Est. primary completion date: June 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• patients with coronary angiography showing chronic coronary total

Exclusion Criteria:

1. Acute coronary syndrome within 3 months.

2. Patients with previous coronary artery bypass graft (CABG).

3. Patients with known renal insufficiency (eGFR < 60 ml/kg/m2, serum creatinine = 2.5 mg/dL, or on dialysis).

Related Conditions & MeSH terms

• Coronary Occlusion

Intervention

Device:
• intravascular ultrasonography
intravascular ultrasonography will be used during the study for the resolving proximal cap ambiguity of chronic total occlusion, facilitating re-entry into the true lumen after subintimal crossing and confirming distal true lumen guidewire position

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (3)

Park Y, Park HS, Jang GL, Lee DY, Lee H, Lee JH, Kang HJ, Yang DH, Cho Y, Chae SC, Jun JE, Park WH. Intravascular ultrasound guided recanalization of stumpless chronic total occlusion. Int J Cardiol. 2011 Apr 14;148(2):174-8. doi: 10.1016/j.ijcard.2009.10.052. Epub 2009 Nov 26. — View Citation

Stone GW, Reifart NJ, Moussa I, Hoye A, Cox DA, Colombo A, Baim DS, Teirstein PS, Strauss BH, Selmon M, Mintz GS, Katoh O, Mitsudo K, Suzuki T, Tamai H, Grube E, Cannon LA, Kandzari DE, Reisman M, Schwartz RS, Bailey S, Dangas G, Mehran R, Abizaid A, Moses JW, Leon MB, Serruys PW. Percutaneous recanalization of chronically occluded coronary arteries: a consensus document: part II. Circulation. 2005 Oct 18;112(16):2530-7. Review. — View Citation

Windecker S, Kolh P, Alfonso F, Collet JP, Cremer J, Falk V, Filippatos G, Hamm C, Head SJ, Jüni P, Kappetein AP, Kastrati A, Knuuti J, Landmesser U, Laufer G, Neumann FJ, Richter DJ, Schauerte P, Uva MS, Stefanini GG, Taggart DP, Torracca L, Valgimigli M, Wijns W, Witkowski A; Grupa Robocza Europejskiego Towarzystwa Kardiologicznego (ESC).; Europejskie Stowarzyszenie Chirurgii Serca i Klatki Piersiowej (EACTS) do spraw rewaskularyzacji miesnia sercowego.; European Association for Percutaneous Cardiovascular Interventions (EAPCI).. [2014 ESC/EACTS Guidelines on myocardial revascularization]. Kardiol Pol. 2014;72(12):1253-379. doi: 10.5603/KP.2014.0224. Polish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	outcomes of intravascular ultrasound guided re-canalized CTO during the procedure and composite of cardiac death, myocardial infarction, or target vessel revascularization	the study will assess the composite of cardiac death, myocardial infarction, or target vessel revascularization, rehospitalization, coronary artery bypass surgery and stroke within both groups	6 months