Clinical trials: Ischemic Lesions
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
Coronary Artery Disease, Coronary Stenosis
Percutaneous Treatment of LONG Native Coronary Lesions With Drug-Eluting Stent-VII: Sirolimus-eluting (Ultimaster) vs. Everolimus-Eluting Stents (Xience)
This study compares angiographic and clinical outcomes in patients with long coronary lesions treated with sirolimus-eluting stent (Ultimaster stent) or everolimus-eluting stent (Xience Alpine stent).
- Trial name
- LONG-DES VII (NCT03484234)
- Testing
- Ultimaster stent, Xience alpine stent
- Where
- 2 sites in South Korea
- Volunteers
- 36 people
- Sponsor
- Seung-Jung Park
Coronary Artery Disease
Study of the Paclitaxel-Coated Balloon Catheter in Bifurcated Coronary Lesions
This study in bifurcated coronary lesions compares the new technology of the paclitaxel-eluting balloon with the usual technique until now of "provisional stenting" with the paclitaxel-eluting stent in the main branch.
- Trial name
- BABILON (NCT01278186)
- Testing
- Balloon angioplasty, Stent implantation
- Where
- 9 sites in Spain
- Volunteers
- 190 people
- Sponsor
- B.Braun Surgical SA
Peripheral Arterial Disease
Tack Optimized Balloon Angioplasty Study of the Tack Endovascular System® in Below the Knee Arteries
This is a prospective, multi-center, single-arm, non-blinded study designed to investigate the safety and efficacy of the Tack Endovascular System in the Mid/Distal Popliteal, Tibial, and Peroneal Arteries ranging in diameter…
- Trial name
- TOBA II BTK (NCT02942966)
- Testing
- Tack Endovascular System
- Where
- 49 sites in United States, Austria and 4 more
- Volunteers
- 233 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Atherosclerotic Heart Disease
Endovascular Treatment of Atherosclerotic Lesions in the SFA Using the Sinus-superflex-635 Stent
In this prospective study, a newly developed self-expanding nitinol stent is evaluated for the treatment of atherosclerotic lesions in the superficial femoral artery and proximal popliteal artery.
- Trial name
- NCT01816854
- Testing
- Stenting
- Where
- Belgium
- Volunteers
- 117 people
- Sponsor
- be Medical
Coronary Artery Stenosis
Main Branch Versus Side Branch Ostial Lesion
The investigators studied the relations between coronary angiography (CAG), intravascular ultrasound (IVUS) and fractional flow reserve (FFR) in coronary ostial lesions.
- Trial name
- NCT01335659
- Testing
- Fractional flow reserve, IVUS
- Volunteers
- 77 people
- Sponsor
- Seoul National University Hospital
Coronary Artery Disease
Two-stent vs Provisional Stenting Techniques for Patients With Complex Coronary Bifurcation Lesions
The purpose of this study is to establish the optimal strategy for stenting in coronary bifurcation lesion.
- Trial name
- DEFINITION-II (NCT02284750)
- Testing
- Percutaneous coronary intervention
- Where
- China
- Volunteers
- 660 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University
Stents, Coronary Artery Disease
First-in-Man Study: Safety and Efficacy of INC-1 Bare Metal Stent in the Novo Coronary Lesions.
This is a First In Man study with the aim to know the safety and effectiveness of a novel bare metal stent (INC-1) in the treatment of de novo coronary lesions in patients with stable coronary angina and unique coronary lessions.
- Conditions
- Stents, Coronary Artery Disease, Angioplasty, Humans
- Trial name
- NCT03375411
- Testing
- Stent INC1
- Where
- Mexico
- Sponsor
- Instituto Nacional de Cardiologia Ignacio Chavez
In-stent Coronary Artery Restenosis
Safety and Efficacy Study of the DANUBIO Paclitaxel Eluting Balloon in In-Stent Restenosis Lesions (DEBREST)
The purpose of this study is to assess safety and efficacy of the Danubio Paclitaxel Eluting Balloon for the treatment of In-Stent Restenosis lesions in native coronary arteries.
- Trial name
- DEBREST (NCT01485068)
- Testing
- Danubio paclitaxel-eluting balloon
- Where
- 8 sites in France
- Volunteers
- 44 people
- Sponsor
- MINVASYS
Coronary Restenosis
Per-cutaneous Intervention Based Paclitaxel and Sirolimus-Eluting Versus Bare Stents for the Treatment of de Novo Coronary Lesions (PAINT)
Objectives: PRIMARY OBJECTIVE: To compare the in-stent late loss at 9 months of paclitaxel- and sirolimus- eluting stents with the late loss of bare metal control stents.
- Trial name
- NCT00752362
- Testing
- Milennium Matrix® (Control), Infinnium®, Supralimus®
- Where
- 11 sites in Brazil
- Volunteers
- 280 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Artery Disease, Coronary Artery Stenosis
Pre-market Study of the DREAMS 2G Drug Eluting Absorbable Metal Scaffold (BIOSOLVE-III)
BIOSOLVE-III Study is a pre-market, prospective, multi-center trial to assess the acute clinical performance of the DREAMS 2G Drug-Eluting Coronary Scaffold in de novo coronary artery lesions.
- Trial name
- BIOSOLVE-III (NCT02716220)
- Testing
- Percutaneous Coronary Intervention
- Where
- 8 sites in Belgium, Germany and 2 more
- Volunteers
- 61 people
- Sponsor
- Biotronik AG
Coronary Artery Disease
Double Rewire Versus Double Kissing Crush Stenting Technique in Left Main Bifurcation Lesions
The DR vs DK trial is designed to elucidate the benefits of Double Rewire crush technique (DR-Crush) over Double Kissing Crush (DK-Crush) technique in patients with Unprotected Left Main Bifurcation lesions (ULMb).
- Trial name
- DR vs DK crush (NCT05258318)
- Testing
- DK crush, DR crush
- Sponsor
- Fundación EPIC
Coronary Artery Disease
The Study of the BX Velocity Stent in the Treatment of De Novo Artery Lesions.
The main objective of this study is to assess the safety and effectiveness of the sirolimus-coated Bx VELOCITY™ stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx…
- Trial name
- C-SIRIUS (NCT00381420)
- Testing
- drug-eluting stent, bare-metal stent
- Volunteers
- 100 people
- Sponsor
- Cordis US Corp.
Coronary Disease, Coronary Artery Disease
SPIRIT II: A Clinical Evaluation of the XIENCE V® Everolimus Eluting Coronary Stent System
Prospective, randomized, active-control, single blind, parallel two-arm multi-center clinical trial comparing XIENCE V® Everolimus Eluting Coronary Stent System to the approved commercially available active control TAXUS™…
- Conditions
- Coronary Disease, Coronary Artery Disease, Coronary Restenosis
- Trial name
- SPIRIT II (NCT00180310)
- Testing
- XIENCE V® Everolimus Eluting Coronary Stent, TAXUS™ EXPRESS2™ Paclitaxel Eluting Coronary Stent
- Where
- 32 sites in Austria, Belgium and 11 more
- Volunteers
- 300 people
- Sponsor
- Abbott Medical Devices
Critical Limb Ischemia (CLI)
Initial Feasibility Study of the STENTiT Resorbable Fibrillated Scaffold (RFS). The RFS is Intended to Restore Lumen Patency and Blood Flow to Infrapopliteal Arteries. The RFS is a Fully Electrospun Tubular Device With a Fibrillated Microarchitecture and Designed for Transcatheter Delivery
This is the First-In-Human feasibility study of the RFS for below the knee lesions in subjects who experience critical limb ischemia due to the peripheral artery disease.
- Trial name
- VITAL-IT 1 (NCT07006467)
- Testing
- Implantation of RFS
- Where
- Austria
- Volunteers
- 10 people
- Sponsor
- Stentit
Dissection, Aortic
sirA-CPB Strategy Reduces New Ischemic/Embolic Lesions After Acute Type A Aortic Dissection Surgery
Type A acute aortic dissection (TAAAD) is a life-threatening disease that typically requires emergency surgery to prevent rupture from causing major bleeding events, with insufficient attention paid to its thromboembolic events.
- Trial name
- NCT07750548
- Testing
- sirA-CPB strategy, the traditional CPB strategy
- Volunteers
- 270 people
- Sponsor
- Xiangya Hospital of Central South University
Coronary Artery Disease
Infinnium-Core™ Registry for the Treatment of Patients With De Novo Coronary Lesions
The primary objective of Infinnium-Core™ Registry is to assess the safety and efficacy of the Infinnium-Core™ Paclitaxel Eluting Coronary Stent System in de novo Coronary Lesions.
- Trial name
- NCT00936780
- Testing
- Infinnium-Core™ Paclitaxel eluting Coronary Stent
- Where
- 7 sites in India
- Volunteers
- 67 people
- Sponsor
- Sahajanand Medical Technologies Limited
Coronary Artery Disease
Non-inferiority Study Comparing Firehawk Stent With Abbott Xience Family Stent (TARGET-AC)
Purpose The TARGET All comers trial is a prospective, multicenter, randomized, two-arm, non-inferiority, open-label study with 1656 patients at 20 centers in Europe. The study is a "real world, all comers" study.
- Trial name
- NCT02520180
- Testing
- Firehawk™ stent system, Abbott Xience family Everolimus-Eluting Stent
- Where
- Denmark
- Volunteers
- 1,653 people
- Sponsor
- Shanghai MicroPort Medical (Group) Co., Ltd.
Arteriosclerosis, Peripheral Artery Disease
Durg Coated Balloon Angioplasty in Infrapopliteal Lesions
This study is a multicenter observational study designed to evaluate the the effectiveness and safety of drug-coated balloon (DCB) angioplasty for below the knee arterial lesions in patients critical with Limb Threatening…
- Conditions
- Arteriosclerosis, Peripheral Artery Disease, Chronic Limb Threatening Ischemia
- Trial name
- Act (NCT05620095)
- Testing
- drug-coated balloon
- Where
- 10 sites in China
- Volunteers
- 1,000 people
- Sponsor
- Liyuan Hospital of Tongji Medical College, Huazhong University of Science and Technology
Coronary Heart Disease
Safety and Efficacy of DCB Therapy for de Novo Lesions Under the Guidance of QFR in CHD Patients (UNIQUE-DCB-I Study )
Since Gruntzig successfully performed percutaneous coronary balloon angioplasty in 1977, percutaneous coronary intervention has developed rapidly.
- Trial name
- NCT04104854
- Testing
- drug coated balloon
- Where
- China
- Volunteers
- 220 people
- Sponsor
- Nanjing First Hospital, Nanjing Medical University