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Stent Restenosis clinical trials

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NCT ID: NCT06276114 Completed - Clinical trials for Coronary Artery Calcification

IVL vs ELCA for Stent Underexpantsion (IVL-ELCA DRAGON)

DRAGON
Start date: August 1, 2020
Phase:
Study type: Observational [Patient Registry]

The IVL- ELCA DRAGON Registry is a multicenter study that enrolled consecutive patients with stent underexpansion treated with IVL ora ELCA in high-volume PCI centers. The primary efficacy endpoint was device success (technical success with a final stent expansion ≥ 80%). Thirty days device-oriented composite endpoint (DOCE: cardiac death, target lesion revascularization, or target vessel myocardial infarction) was the secondary endpoint.

NCT ID: NCT06112028 Not yet recruiting - Stent Restenosis Clinical Trials

Clinical Study of Tongxinluo Capsule in Preventing and Treating Restenosis After Intracranial and External Arterial Stenting

Start date: October 2023
Phase: Phase 4
Study type: Interventional

Intrastent restenosis is a common complication after intracranial and extracranial arterial stenting and an important cause of recurrent ischemic stroke. Studies have shown that Tongxinluo capsule can protect the injured inner cells, reduce inflammation, inhibit the proliferation and migration of smooth muscle cells, inhibit the proliferation of plaque and nourish blood vessels, and resist arteriosclerosis. This study was a multicenter prospective randomized controlled clinical trial. Participants with intracranial and extracranial atherosclerotic stenosis who successfully underwent arterial stenting were included in the study, and were divided into Tongxinluo test group and control group. Clinical and related auxiliary examination data were collected at each follow-up point. To explore the effectiveness and potential mechanism of Tongxinluo capsule in preventing and treating restenosis after intracranial and external arterial stenting, and to provide reference for expanding clinical use of traditional Chinese medicine.

NCT ID: NCT05591365 Completed - Clinical trials for Coronary Artery Disease

Exercise Training in Coronary Artery Disease Patients After Stenting

Start date: October 18, 2022
Phase: N/A
Study type: Interventional

To determine the effect of exercise training on cardiac outcomes in coronary artery disease patients after Stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after PCI.

NCT ID: NCT05346068 Recruiting - Clinical trials for Coronary Artery Disease

The Value of IVL Compared To OPN Non-Compliant Balloons for Treatment of RefractorY Coronary Lesions (VICTORY) Trial

VICTORY
Start date: November 22, 2022
Phase: N/A
Study type: Interventional

Percutaneous coronary intervention (PCI) with drug-eluting stent (DES) implantation has become the dominant treatment strategy for patients with acute and chronic coronary artery disease (CAD) requiring revascularization. Nonetheless, PCI with stent implantation has some limitations and especially patients with severely calcified coronary lesions (approximately 10-20% of all patients with CAD) have an elevated risk for adverse outcomes, including target lesion failure (TLF) and stent thrombosis (ST). Several dedicated PCI devices have been developed for treatment of severely calcified lesions. Whereas especially two of them have shown promising results in smaller, prospective studies. First, the super high-pressure NC PCI balloon (OPN™ NC, SIS Medical AG, Frauenfeld, Switzerland) has been shown to represent an effective and safe device for lesion preparation. Second, the lately introduced Shockwave intravascular lithotripsy (IVL)™ balloon catheter (Shockwave Medical, Santa Clara, CA, USA) appears to be a safe and efficient alternative device for treatment of calcified coronary lesions. However, it remains unknown, if the OPN™ NC balloon is non-inferior to to IVL regarding lesion preparation and completeness of stent expansion in severely calcified lesions.

NCT ID: NCT05315193 Completed - Clinical trials for Coronary Artery Disease

Effect of Exercise Training in Coronary Artery Disease Patients After Stenting

Start date: October 18, 2022
Phase: N/A
Study type: Interventional

To determine the effects of exercise training on ankle-brachial index and Quality of Life in coronary artery disease patients after stenting. There is a need to develop strategies, not only to prevent restenosis but also to improve patients' functional status and perception of well-being. In particular, it is not well defined whether exercise training can reduce the restenosis rate and improve the outcome after percutaneous intervention (PCI), and its effects on the Ankle-brachial index are not yet well known.

NCT ID: NCT05244629 Recruiting - Stent Thrombosis Clinical Trials

Copenhagen Mesenteric Stent Study - A Randomized Trial of Stent Versus Covered Stent Treatment for Chronic Mesenteric Ischemia

COMESS
Start date: June 2023
Phase: N/A
Study type: Interventional

Chronic mesenteric ischemia (CMI) is often caused by narrowings in the arteries providing blood to the intestines. Endovascular stent placement is considered the preferred treatment for this condition. Guidelines increasingly support the use of so called covered stents (CS) in stead of bare stents (BMS) for this use but the level of evidence for this is limited. Using CS incur additional costs for healthcare short-term but may prevent recurrence of narrowing and symptoms postoperatively benefitting patients and healthcare. Study Objective: To evaluate the outcomes after stenting of mesenteric arteries using BMS or CS. Study Outcome: Primary stent patency 1 year after placement The trial will also evaluate complications, how often stents need to be reoperated, Quality of Life (QoL) and reasons for subjects death Method: This is a so called prospective, randomized controlled trial comparing CS vs. BMS. This means that one patients have agrred to treatment they will be randomly selected for treatment with either CS or BMS . The stent metal structure is identical in the two implants and the only difference is the graft covering, making this study unique. The study will also collect blood samples for a biobank that will be used to study markers of disease and how these effect treatment outcomes. All patients referred to the Department of Vascular Surgery due to CMI are considered for inclusion if they havechronic symptoms consistent with CMI, significant stenosis or occlusion of the superior mesenteric artery and are > 18 years Subjects not able to provide informed consent or who have non atherosclerotic cause of CMI, signs of acute loss of blood flow to the intestines cannot participate. Previous stent treatment in the superior mesenteric artery, pregnancy, allergies to contrast or stent materials are also reasons for not being included in this trial. Side effects, risks and disadvantages for participants The risk for procedure-related complications is less than 5% and similar in both study groups. Most short-term complications are related to vascular access sites and consist of local bleeding and thrombosis. Other potential complications include impaired renal function due to contrast use, contrast allergy, arterial dissection and death.

NCT ID: NCT05217459 Completed - Stent Restenosis Clinical Trials

The Efficacy and Safety of Intracranial Self-expanding DES in Symptomatic Intracranial Atherosclerotic Disease

Start date: July 4, 2022
Phase: N/A
Study type: Interventional

The primary objective of this trial is to evaluate the safety and efficacy of SINOMED IS- DES in patients with symptomatic intracranial atherosclerotic stenosis.

NCT ID: NCT05205148 Recruiting - Clinical trials for Coronary Artery Disease

Ultrathin DES in Complex PCI Scenarios: the ULTRA a Multicenter Study

ULTRA
Start date: January 1, 2019
Phase:
Study type: Observational [Patient Registry]

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, chronic total coronary occlusion, and in-stent restenosis regardless of their clinical presentation. Target lesion failure (TLF a composite endpoint of cardiovascular death, target vessel myocardial infarction, target lesion revascularization and definite stent thrombosis) will be the primary end point, while its single components will be the secondary ones along with all-cause death, all acute myocardial infarction (excluding peri-procedural AMI), target vessel revascularization and BARC major bleedings (BARC 3-5). Due to the retrospective, observational nature of the registry, no formal sample size estimation is required. Patients complying with detailed inclusion criteria and with a minimum follow up of 6 months will be enrolled.

NCT ID: NCT04325867 Recruiting - Hypertension Clinical Trials

Integrated Distance Management Strategy for Patients With Cardiovascular Diseases in the Context of COVID-19

eCardioCovid19
Start date: March 31, 2020
Phase: N/A
Study type: Interventional

Management of known patients with cardiovascular disease (in particular the whole spectrum of atherosclerotic ischaemic coronary artery disease, essential hypertension under treatment, and also patients with chronic heart failure under medication) and with other associated chronic pathologies, with obvious effects on the management of the pandemic with modern / distance means (e-Health) of patients at high risk of mortality in contact with coronavirus. Given the Covid-19 Pandemic, all the above complex cardiovascular patients are under the obligation to stay in the house isolated and can no longer come to standard clinical and paraclinical monitoring and control visits. Therefore, a remote management solution (tele-medicine) of these patients must be found. The Investigators endeavour is to create an electronic platform to communicate with these patients and offer solutions for their cardiovascular health issues (including psychological and religious problems due to isolation). The Investigators intend to create this platform for communicating with a patient and stratify their complaints in risk levels. A given specialist will sort and classify their needs on a scale, based on specific algorithms (derived from the clinical European Cardiovascular Guidelines), and generate specific protocols varying from 911 like emergencies to cardiological advices or psychological sessions. These could include medication changing of doses, dietary advices or exercise restrictions. Moreover, in those patients suspected of COVID infection, special assistance should be provided per protocol.

NCT ID: NCT03544294 Completed - Stent Thrombosis Clinical Trials

veRy Thin Stents for Patients With Left mAIn or bifurcatioN in Real Life: the RAIN a Multicenter Study

RAIN
Start date: June 1, 2017
Phase:
Study type: Observational [Patient Registry]

For permanent coronary stents, reduction of thickness of struts have become one of the most important innovation, being related to easier manipulation, reduced risk of stent thrombosis and low rate of revascularization. Consequently the investigators performed a multicenter registry enrolling all consecutive patients treated with very thin stents for ULM or bifurcation.