Clinical trials: Complex Coronary Lesions
Coronary Artery Disease
Optical CoherenCe Tomography-gUided Coronary Intervention in Patients With Complex lesIons: a Randomized Controlled Trial (OCCUPI Trial)
There is no definite conclusive work about the benefit of OCT-guided PCI, which should be determined in complex PCI, assuming better stent optimization by OCT.
- Trial name
- NCT03625908
- Testing
- OCT-guided PCI, Angiography-guided PCI
- Where
- South Korea
- Volunteers
- 1,604 people
- Sponsor
- Yonsei University
Complex Coronary Lesions
Complex Large-bore Radial Percutaneous Coronary Intervention (PCI) Trial
The COLOR trial is a Multicenter Randomized trial. Patients are eligible for study participation when PCI is indicated for complex coronary lesions.
- Trial name
- Color (NCT03846752)
- Testing
- radial artery access for complex PCI, femoral artery access for complex PCI
- Where
- 12 sites in Belgium, Germany and 3 more
- Volunteers
- 388 people
- Sponsor
- Maatschap Cardiologie Zwolle
Ischemic Heart Disease, Coronary Artery Disease
A Prospective Study, Single-arm, Multicentre, Observational to Evaluate Safety and Effectiveness of Stent Ultimaster Tansei Coronary Stent in Complex Coronary Lesions.
This prospective registry is intended to evaluate the safety and efficacy of the TANSEI stent.
- Trial name
- TANSEI (NCT04475536)
- Testing
- TANSEI stent
- Where
- 17 sites in Spain
- Volunteers
- 501 people
- Sponsor
- Fundación EPIC
Coronary Artery Disease, Coronary Stenosis
Reverse T-stenting and Minimal Protrusion With External Minicrush for Treatment of Complex Coronary Bifurcation
The Reverse T-stenting And Minimal Protrusion (Reverse TAP) is an up-front 2-stent technique that treats complex coronary bifurcation.
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Coronary Disease
- Trial name
- T-REX (NCT05782738)
- Testing
- Percutaneous Coronary Intervention
- Where
- 5 sites in Italy
- Volunteers
- 361 people
- Sponsor
- San Luigi Gonzaga Hospital
True Coronary Bifurcation Lesions
COmplex BifuRcation Lesions: a Comparison Between the AXXESS Device and Culotte Stenting: an Optical Coherence Tomography (OCT) Study
Treatment of bifurcation lesions with drug-eluting stents (DES) (especially when a double stent technique is used) is associated with a higher risk for stent thrombosis.
- Trial name
- COBRA (NCT01486095)
- Testing
- AXXESS + Biomatrix Biolimus Eluting stent, Culotte technique with Xience V or Xience Prime stents
- Where
- 2 sites in Belgium
- Volunteers
- 40 people
- Sponsor
- Universitaire Ziekenhuizen KU Leuven
Coronary Artery Disease
Stenting With or Without Coating Compared With Angioplasty in Non-benestent Disease
The purpose of this study is to evaluate the clinical and angiographic outcome of implantation of stents eluting or not eluting Sirolimus in patients with complex coronary artery lesions suitable for percutaneous coronary…
- Trial name
- NCT00192881
- Testing
- Bx Sonic & Cypher stent from Cordis
- Where
- Denmark
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Coronary Artery Disease
SMart Angioplasty Research Team: CHoice of Optimal Anti-Thrombotic Strategy in Patients Undergoing Implantation of Coronary Drug-Eluting Stents 3
This study is a prospective, open-label, two-arm, randomized multicenter trial to compare the efficacy and safety of clopidogrel versus aspirin monotherapy beyond the standard duration of dual antiplatelet therapy (DAPT) (more…
- Trial name
- SMART-CHOICE3 (NCT04418479)
- Testing
- Aspirin, Clopidogrel
- Where
- South Korea
- Volunteers
- 5,506 people
- Sponsor
- Joo-Yong Hahn
Coronary Artery Disease
Study Examining the PROMUS Element Everolimus-eluting Stent in Multi-center Coronary Intervention of Complex Arterial Lesion Subsets
Randomized trials have demonstrated an excellent safety and efficacy profile for the chromium everolimus-eluting stent. The platinum chromium everolimus-eluting sten (PtCr-EES) uses the identical antiproliferative agent and…
- Trial name
- SPECIALIST (NCT01670318)
- Testing
- platinum chromium everolimus-eluting stent (PROMUS Element by Boston Scientific, Massachusetts)
- Where
- 38 sites in Japan
- Volunteers
- 800 people
- Sponsor
- The PCI Guideline Research Society
Coronary Artery Disease
Do Cobalt Chrome Stent and Paclitaxel-Eluting Stent Have Equivalent Clinical Result in Non-Complex Lesion?
We sought to evaluate the long-term safety and efficacy of drug-eluting stent in large vessels compared with bare metal stent.
- Trial name
- COPE (NCT00852215)
- Testing
- Taxus stent, Vision stent
- Where
- South Korea
- Volunteers
- 500 people
- Sponsor
- Samsung Medical Center
Coronary Artery Disease, Coronary Stenosis
Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study
ULTRA is a multicenter, observational, retrospective registry, enrolling consecutive patients treated with ultrathin coronary DES (coronary stent with strut thickness < 70 um) for coronary bifurcation lesions, left main disease…
- Conditions
- Coronary Artery Disease, Coronary Stenosis, Stent Restenosis, Left Main Coronary Artery Disease
- Trial name
- ULTRA (NCT05205148)
- Testing
- Percutaneous coronary intervention with the following platforms: Orsiro; Mistent; BioMime; Supraflex Cruz
- Where
- Italy
- Volunteers
- 1,000 people
- Sponsor
- A.O.U. Città della Salute e della Scienza
Coronary Artery Stenosis
Study of BioNIR Drug Eluting Stent System in Coronary Stenosis
The BioNIR study aims to show that the BioNIR ridaforolimus eluting stent is non-inferior to the Resolute zotarolimus-eluting stent for the primary clinical endpoint of target lesion failure (TLF) at 12 months; that it is…
- Trial name
- BIONICS (NCT01995487)
- Testing
- BioNIR, Resolute
- Where
- 8 sites in United States, Belgium and 6 more
- Volunteers
- 1,919 people
- Sponsor
- Medinol Ltd.
Percutaneous Coronary Revascularisation, Complex Coronary Lesion
Use of Physiology to Evaluate Procedural Result After PCI CTO
ULTRA-CTO is a prospective multicentre non-randomised investigator-initiated trial designed to enrol 200 subjects with an indication for percutaneous coronary intervention (PCI) of chronic total occluded (CTO) coronary artery.
- Trial name
- ULTRA-CTO (NCT04780971)
- Testing
- post-PCI Pd/Pa
- Where
- 2 sites in Netherlands
- Volunteers
- 200 people
- Sponsor
- Isala
Coronary Heart Disease
A Cohort Study of PCI Strategies for Severely Calcified Lesions of Complex Coronary Arteries in the Elderly
The aim of this observational study is to compare the prognostic outcomes of various PCI strategies in elderly patients with complex coronary calcified lesions.
- Trial name
- PSSCCE (NCT06168422)
- Testing
- DES, DCB
- Where
- China
- Volunteers
- 2,100 people
- Sponsor
- Henan Institute of Cardiovascular Epidemiology
Coronary Atherosclerosis Due to Calcified Coronary Lesion, Chronic Total Occlusion of Coronary Artery
The XLIMUS-DES in Very Complex Lesions
Stent delivery failure occurs in 4% of all percutaneous coronary interventions (PCI) and >90% of these failures are due to vessel tortuosity and/or calcification.
- Trial name
- NCT02360020
- Testing
- XLimus
- Where
- Italy
- Volunteers
- 200 people
- Sponsor
- Clinica Mediterranea
Coronary Artery Disease
Efficacy and Safety of Firebird 2 Stent in Treatment of Complex Coronary Lesions in Diabetes
The goal of this study is to assess the long-term efficacy and safety of Firebird2 Cobalt-Chromium（CoCr）-alloyed sirolimus-eluting stent in treatment of complex lesions in diabetes.
- Trial name
- NCT01257373
- Testing
- Firebird 2 Cobalt-Chromium Alloyed Sirolimus-Eluting Stent
- Where
- China
- Volunteers
- 1,300 people
- Sponsor
- Xijing Hospital
Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI)
Double Kissing-crush vs Controlled Balloon-crush Techniques For Complex Coronary Bfurcation Lesions
The Crush technique for coronary bifurcation lesions has evolved significantly since its introduction to the literature by Colombo et al. in 2003, with several iterations, including double kissing balloon inflation.
- Conditions
- Coronary Arterial Disease (CAD), Percutaneous Coronary Intervention (PCI), Bifurcation Coronary Disease
- Trial name
- NCT06931574
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 300 people
- Sponsor
- Istanbul Mehmet Akif Ersoy Educational and Training Hospital
Coronary Artery Disease
IVUS-guided DK Crush Stenting Technique for Patients With Complex Bifurcation Lesions
This study is designed to investigate whether IVUS-guided DK crush stenting technique compared to angiography-guided DK crush after the indexed procedure will lead to lower rates of the composite endpoint of target vessel failure…
- Trial name
- DKCRUSH-VIII (NCT03770650)
- Testing
- Stenting
- Where
- China
- Volunteers
- 556 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Cardiovascular Disease, Coronary Artery Occlusion
Ultimaster Nagomi™ Sirolimus Eluting Coronary Stent System in Complex PCI Patients
The NAGOMI COMPLEX PMCF (Post-Market Clinical Follow-up) study has been designed to expand the knowledge about outcomes with the Ultimaster Nagomi™ sirolimus eluting coronary stent system (Ultimaster Nagomi™) in complex PCI…
- Conditions
- Cardiovascular Disease, Coronary Artery Occlusion, Ischemic Heart Disease
- Trial name
- NAGOMI COMPLEX (NCT05705973)
- Testing
- Ultimaster Nagomi™
- Where
- 52 sites in Austria, Belgium and 11 more
- Volunteers
- 3,000 people
- Sponsor
- Terumo Europe N.V.
Angioplasty
Evaluation of Practices and Prognostic Factors of Percutaneous Coronary Interventions (PCI) of Calcified Complex Lesions Using Rotational Atherectomy Device.
In spite of technological advances, PCI of complex calcified coronary lesions remain a challenge. Observational studies demonstrate that moderate or severe calcifications in lesions to treat are associated with an increase in…
- Trial name
- Eurotaclub (NCT03673254)
- Testing
- rotational atherectomy device
- Where
- 16 sites in Austria, France and 6 more
- Volunteers
- 1,026 people
- Sponsor
- University Hospital, Toulouse
Coronary Artery Disease
A Study of Drug Coated Balloon For Treating the Side Branch in Complex Bifurcation Lesions
Hypothesis: In patients undergoing coronary stenting for the true bifurcation lesions, main branch stenting followed by side branch dilatation with drug coated balloon is superior to the provisional-stenting strategy in terms of…
- Trial name
- STENT-FREE (NCT05222061)
- Testing
- Drug coated balloon for the side brunch, Conventional balloon for the side brunch
- Where
- Russia
- Volunteers
- 80 people
- Sponsor
- Meshalkin Research Institute of Pathology of Circulation